Enrolling Studies Now

The AURORA study (CVC)

Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH.

Inclusion Criteria:

  1. Male and female subjects aged between 18-75 years
  2. Ability to understand and sign a written informed consent form (ICF)
  3. Histological evidence of NASH based on central reading of the Screening biopsy
  4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides
  5. Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and serum follicle-stimulating hormone (FSH) ≥ 30 mU/mL at Screening.

Exclusion Criteria:

  1. Inability to undergo a liver biopsy
  2. Hepatitis B surface antigen (HBsAg) positive
  3. Hepatitis C antibody (HCVAb) positive
  4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
  5. Prior or planned liver transplantation
  6. Other known causes of chronic liver disease

Study on CC-90001

Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Non-alcoholic Steatohepatitis (NASH) and Stage 3 or Stage 4 Liver Fibrosis. 

Inclusion Criteria:

  • Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 3 or Stage 4 fibrosis based of the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher

Exclusion Criteria:

- Key Exclusion Criteria

  1. History or evidence of decompensated liver disease,
  2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
  3. Subject has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening.
  4. History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency [CVID]).
  5. History of hepatitis B and/or hepatitis C.

The TRAVERSE Study

A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men.

Inclusion Criteria:

  • Men between 45 and 80 years age
  • Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

Exclusion Criteria:

  • Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
  • Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
  • Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
  • Confirmed testosterone < 100 ng/dL
  • Body Mass Index (BMI) > 50
  • Hemoglobin A1c (HbA1C) > 11%

The MIRO Study

Mobile Assessment of Neurocognitive and Psychological Function: A Case-Controlled, Prospective Observational Non-Inferiority Study in Age-Matched Cohorts of Healthy Adults and Adults with Mild Cognitive Impairment.

Inclusion Criteria

  • Males and Females 65 and Older
  • Must be able to Speak, Read and Write in English
  • Must be okay with prolonged testing on Ipad

The V1ADUCT Study

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension.

Inclusion Criteria:

  • Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 criteria
  • SRS-2, proxy version, total t-score >=66 at screening
  • A full scale IQ score >=70 on the WASI®-II
  • Subject has an appropriate study partner, in the opinion of the investigator
  • For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of <1% per year during the treatment period and for at least 28 days after the last dose of study drug
  • Treatment with permitted medications (at a stable dose for 12 weeks before screening) and behavioral therapy regimens (regimens stable for 6 weeks before screening), with the intent that such treatments remain stable throughout the study and with no expected changes before the Week 24 visit

Exclusion Criteria:

  • Pregnancy or breastfeeding, or intention to become pregnant during the study
  • Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
  • Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
  • Substance use disorders during the last 12 months
  • Significant risk for suicidal behavior, in the opinion of the investigator
  • Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
  • Clinical diagnosis of peripheral neuropathy

The OTZUKA Study

A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder.

Inclusion Criteria:

  • Male and Female subjects between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)

Exclusion Criteria:

  • Index trauma event >15 years before screening
  • Index trauma event at age <16
  • Any traumatic event within 3 months of screening

Clinical Trial on Oral Ziprasidone

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder. 

Inclusion Criteria

  • Evidence of personally signed and dated informed consent document by the legal representative and an assent document by the subject .
  • Subjects and their legal guardians who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • The subjects must have received investigational product in Study A1281198 and completed at least 3 weeks of double blind treatment before entering this open label extension.
  • In the investigator's opinion, the subject must be likely to benefit from antipsychotic therapy .
  • All fertile male subjects and female subjects of childbearing potential who are sexually active and/or their legal guardians, as appropriate, must agree that a highly effective method of contraception

Exclusion Criteria

  • Any subjects from the preceding double blind trail who experienced a serious adverse event which required study medication to be discontinued and the subject to be withdrawn from the study. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persistent Fridericia's correction (QTcF) >480 msec or increase from baseline QTcF >60 msec) during the preceding study.
  • Subjects requiring any medications not allowed by the Concomitant Medication Table 12 (see "Concomitant Treatment(s)").
  • Subjects who require treatment with drugs that are known to consistently prolong the QT interval (see Concomitant Medication Table 12).
  • Subjects who are judged by the investigator as being at imminent risk of suicide.
  • Subjects living in the same home as another study participant or having the same caregiver during the same enrollment period (Such subjects can be enrolled in the study at different times but may not be in the study at the same time).

Studies on Risankizumab (M15-991; M16-000; M16-006)

A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease. Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
  • Diagnosis of CD for at least 3 months prior to Baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

Exclusion Criteria:

  • Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
  • Subjects with unstable doses of concomitant Crohn's disease therapy
  • Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
  • Prior exposure to p19 inhibitors (e.g., risankizumab)
  • Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
  • Having an ostomy or ileoanal pouch"

Studies on Ozanimod (RPC01-3202; RPC01-3203; RPC01-3204)

Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease.

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Aged 18-75 years
  2. Crohn's disease for ≥ 3 months on endoscopy and on histological exam
  3. Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
  4. Patient has met each of the following 2 criteria: 1) Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450. 2) Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment or at the time point specified in the following criteria:

  1. Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis or known strictures or stenosis leading to symptoms of obstruction.
  2. Current stoma, ileal-anal pouch anastomosis, symptomatic fistula, or need for ileostomy or colostomy

Or… Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject fulfilled the inclusion criteria at time of entry into the Induction Study (RPC01-3201 or RPC01-3202) and have completed the Week 12 efficacy assessments of the Induction Study.
  2. Subject is in clinical response (a reduction from baseline in Crohn's Disease Activity Index (CDAI) of ≥ 100 points or CDAI score of < 150 points) or in clinical remission based on an average stool frequency score ≤ 3 with a stool frequency no worse than baseline and an average abdominal pain score ≤ 1 or CDAI score of < 150 points at Week 12 of the Induction Study.

Or… Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subjects who are not in clinical response or clinical remission after completing 12 weeks in the Induction Studies RPC01-3201 or RPC01-3202, subjects who experience relapse or who complete the Maintenance Study RPC01-3203, and subjects who complete a study of ozanimod for Crohn's Disease and meet the criteria for participation in the RPC01-3204 Study will have the opportunity to participate in this study.
  2. Must be male or female subjects aged 18 to 75 years (at Pre-baseline), inclusive.
  3. Subject must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events.
  4. Female subjects of childbearing potential

The MANDALA Study

A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older with Asthma.

Inclusion Criteria:

  1. Female or male aged ≥4 years at the time of informed consent
  2. Physician diagnosis of asthma documented for at least 1 year
  3. Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1:
    • Medium-to-high-dose inhaled corticosteroid (ICS)
    • Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
    • Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
  4. Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to <90% predicted normal value for adults and adolescents, and ≥60 to <100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA)
  5. Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry. One re-test for reversibility testing is allowed within the screening period in advance of Visit 2
  6. Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
  7. A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
  8. Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
  2. Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
  3. Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
  4. Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication
  5. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
  6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years of Visit 1
  7. Historical or current evidence of a clinically significant disease
  8. Cancer not in complete remission for at least 5 years
  9. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1

The DENALI Study

A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older with Asthma

Inclusion Criteria:

  1. Female or male aged ≥4 years at the time of informed consent
  2. Physician diagnosis of asthma with a documented history of the last 6 months
  3. Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:
    • Only short/rapid-acting β2-adrenoreceptor agonist (SABA) used as needed
    • Stable low-dose inhaled corticosteroid in addition to as-needed use of SABA
  4. Pre-bronchodilator FEV1 of ≥50 to <85% predicted normal value for adults (≥18 years of age) and ≥50 to <90% predicted normal value for subjects aged 4 to 17 years after withholding SABA ≥6 hours at Visit 1.
  5. Demonstrate reversibility of airflow limitation defined as a ≥15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a.
  6. Demonstrate acceptable spirometry performance acceptability/repeatability criteria
  7. Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
  8. Demonstrate acceptable MDI administration technique as assessed by the investigator.
  9. Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
  2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
  3. Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
  4. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
  5. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
  6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
  7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
  8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
  9. Hospitalizations due to asthma within 6 months prior to Visit 1

Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease (HOPE4MCI)

A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3372993 in Healthy Subjects and Patients with Alzheimer's Disease.

Inclusion Criteria:

  • Subjects between 55 and 85 years old (inclusive) in good general health:
    • Willing and able to consent and participate for the duration of the study
    • Have eighth-grade education or good work history sufficient to exclude mental retardation
    • Have visual and auditory acuity adequate for neuropsychological testing
    • Have proficient fluency of the native local language to participate in all the neuropsychological test assessments
  • Have a study partner who has sufficient contact with the subject to be able to provide assessment of memory changes, who can accompany the subject to all the clinic visits for the duration of each visit, and who is able to provide an independent evaluation of the subject's functioning
  • Have MCI due to AD as defined by all of the following criteria and consistent with the National Institute on Aging-Alzheimer's Association criteria:
    • MMSE scores between 24 and 30 (inclusive; exceptions may be made for subjects with <8 years of education at the discretion of the sponsor)
    • A memory complaint reported by the subject or his/her study partner
    • Evidence of lower memory performance based on delayed recall in the International Shopping List Test (ISLT)
    • A clinical dementia rating (CDR) score of 0.5 with a memory box score of ≥0.5
    • Essentially preserved activities of daily living
    • Cognitive decline not primarily caused by vascular, traumatic, or medical problems (alternative causes of cognitive decline are ruled out)
  • Permitted medications:
    • With potential pro-cognitive effects, such as cholinesterase inhibitors and memantine, must be at a stable dose for ≥3 months prior to screening and remain stable throughout the study; estrogen replacement therapy, Ginkgo biloba, and vitamin E must be at a stable dose for ≥4 weeks prior to screening and remain stable throughout the study
    • Other psychotropics, such as antidepressants and antipsychotics, must be at a stable dose for ≥3 months prior to screening and remain stable throughout the study
  • Willing and able to undergo imaging procedures:
    • A Positron Emission Tomography (PET) scan with Florbetaben(an 18F isotope diagnostic agent) or documented evidence of an amyloid positive PET scan.

      The Florbetaben scan performed at baseline must be read by a qualified physician with experience in reading amyloid PET scans, and it should be consistent with the presence of amyloid plaques.

    • Repeated MRI scans (3 Tesla) with no contraindications to MRI. MRI scan results are consistent with the diagnosis of amnestic MCI due to Alzheimer's disease with no clinically significant findings of non-AD pathology that could account for the observed cognitive impairment.
    • Willing to allow collection of blood for apolipoprotein E (ApoE) genotyping.

Exclusion Criteria:

  • Use of anticonvulsant medications or excluded psychotropic medications within 3 months prior to the baseline visit
  • Participation in a therapeutic clinical study for any medical or psychiatric indications within 3 months (6 months for biologics) of the screening visit, or at any time during the study.

    Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose/administration was received within 3 months (6 months for biologics) prior to screening.

  • History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam)
  • Severe renal impairment (creatinine clearance of <30 mL/minute) or undergoing hemodialysis
  • Any significant neurological disease other than suspected incipient AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
  • Diagnosis of major depression or bipolar disorder, as described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed (DSM-5), within the past 3 years.
  • Psychotic features, agitation, or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol. Subjects must not have a major depressive disorder or other types of depression that could confound diagnosis of MCI due to AD, or clinical assessments, in the opinion of the investigator. The geriatric depression scale (long form score >9 suggests depression) results should be reviewed by the investigator to assist in this determination.
  • Modified Hachinski Ischemic Scale (HIS) score >4
  • History of schizophrenia (DSM-5 criteria)
  • History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria)
  • Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
  • Clinically significant abnormalities in B12 or thyroid function test that might interfere with the study.

    A low B12 (below normative range for elderly) is exclusionary, unless follow-up labs (homocysteine and methylmalonic acid) indicate that it is not physiologically significant. If the B12 deficiency is treated, subjects may become eligible to participate in the study."

AR1001 For Alzheimer’s Disease

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients with Mild to Moderate Alzheimer's Disease.

Inclusion Criteria:

  1. Male or female subjects aged 55-75 years at the time of signing the Informed Consent form.
  2. Subjects (or subject's legally acceptable representative) and caregivers who can sign an Informed Consent to participate in the study.
  3. Subjects who have a diagnosis of probable mild-to-moderate Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association) criteria at the screening and baseline visits.
  4. Subjects who have an MMSE Score of 16-26 at the screening and baseline visits.
  5. Subjects who have an MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies.
  6. Subjects who have one (or more) identified adult study partner(s) who, in the opinion of the investigator, has sufficient contact with and knowledge about the subject as to be able to report knowledgeably about the subject's safety, compliance and adherence, cognition, function, and behavior.

Exclusion Criteria:

  1. Subjects who are female who are pregnant, nursing, or of childbearing potential and not practicing effective contraception.
  2. Subjects who have signs of delirium.
  3. Subjects who have had cortical stroke within the preceding 2 years.
  4. Subjects who have any diagnosis of dementia other than that related to Alzheimer's Disease, including concomitant vascular dementia.
  5. Subjects who have uncontrolled cardiac disease or hypertension.
  6. Subjects who have clinically significant renal or hepatic impairment.
  7. Subjects who have cancer or a malignant tumor, untreated thyroid disorder, or a history of seizure disorder.

The PEGASUS Study

Phase II Study to Assess the Safety, Tolerability, and Target Engagement of AMX0035, a Fixed Combination of Sodium Phenylbutyrate and Tauroursodeoxycholic Acid for the Treatment of Alzheimer's Disease.

Inclusion Criteria:

  1. Ages 55-89, inclusive, male or female
  2. Diagnosis of "Probable Alzheimer's Disease" or Mild Cognitive Impairment (amnestic or amnestic plus other) with biomarkers that suggest intermediate or high likelihood that the syndrome is due to AD, according to 2011 NIA-AA Workgroup criteria
  3. MoCA 8 - 26 inclusive
  4. Able to read and write in English sufficiently to complete all study procedures
  5. Geriatric Depression Scale <7
  6. Willing and able to complete all assessments and study procedures
  7. Not pregnant, lactating or of child-bearing potential (women must be >2 years post-menopausal or surgically sterile)
  8. Study partner with at least two days per week with contact with patient willing to accompany patient to visits and complete partner study forms
  9. No known hypersensitivity to Tauroursodeoxycholic acid or Phenylbutyrate
  10. Must have a previous biomarker supportive of AD as the underlying pathology of cognitive decline, which could include amyloid PET, CSF AD biomarkers, FDG-PET, or vMRI scan
  11. If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline

Exclusion Criteria:

  1. Any CNS disease other than suspected AD, such as clinical stroke, brain tumor, normal pressure hydrocephalus, multiple sclerosis, significant head trauma with persistent neurological cognitive deficits or complaints, Parkinson's disease, frontotemporal dementia, or other neurodegenerative diseases
  2. Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of normal
  3. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal
  4. History of cholecystectomy or biliary disease

A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

Inclusion Criteria:

  • Subjects with a diagnosis of probable Alzheimer's disease.
  • Subjects with a diagnosis of agitation
  • Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
  • Subjects with a previous MRI or CT scan of the brain, that was performed after the onset of symptoms of dementia, with findings consistent with a diagnosis of Alzheimer's disease.
  • Subjects who are residing at their current location for at least 28 days before screening and are expected to remain at the same location for the duration of the trial.
  • Institutionalized subjects with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms and has direct observation of the subject's behavior. Non-institutionalized subjects may not be living alone and must have an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms and has direct observation of the subject's behavior.
  • Subjects with onset of symptoms of agitation at least 2 weeks prior to screening visit.
  • Subjects will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.

Exclusion Criteria:

  • Subjects with dementia or other memory impairment not due to Alzheimer's disease.
  • Subjects with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
  • Subjects who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
  • Subjects who have been diagnosed with an Axis I disorder.
  • Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
  • Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
  • Subjects with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.

The ELEVATE Study

Inclusion criteria:

  1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
  2. Active UC confirmed by endoscopy

Exclusion criteria:

  1. Severe extensive colitis
  2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
  3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

LUCENT 1, LUCENT 2, LUCENT 3 and ADP443 (Etrasimod)

A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis and An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis.

Inclusion Criteria: Male and Females 16-80 years old.

  • Must have met the eligibility criteria and have been enrolled in one of the two parent studies (APD334-301 or APD334-302) and also meet the following additional criteria:
    1. Participants previously enrolled in Study APD334-301 must have completed the Week 12 visit and have been assessed to have active UC that had deteriorated from baseline or completed the Week 52 visit
    2. Participants previously enrolled in APD334 302 must have completed the Week 12 visit

Exclusion Criteria:

  • If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
  • Experienced an adverse event that led to discontinuation from one of the parent studies

A History of Research in Miami

After 11 years of performing research studies in South Florida we are proud to continue to work with our Medical Partners in order to find cures to terrible conditions and find ways to benefit our patient’s quality of life. We have an amazing track record and are known for our patient care focus and our commitment to the progress of medicine and science.

We post all current and future studies with
news on medical research on our social
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FOLLOW US and research
with us!!”

We post all current and future studies with news on medical research
on our social
media pages...
FOLLOW US and research
with us!!”