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Therapeutic Areas: Neurology | Family Medicine
Disease Category: Alzheimer's Disease
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

A Phase 3, double blind, randomized study of RVT-101 versus placebo when added to existing stable donepezil treatment in subjects with mild to moderate Alzheimer’s disease

Purpose

The primary objectives of this study are to assess the effects of RVT-101 versus placebo as adjuncts to stable donepezil therapy on cognitive function as measured by the Alzheimer’s Disease Assessment Scale - Cognitive Subscale 11 items (ADAS-Cog-11) after 24 weeks of treatment AND on activities of daily living as measured by the Alzheimer’s Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale after 24 weeks of treatment.

To Learn more

CW ID: 213388
Date Last Changed: February 15, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
50 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Axovant Sciences, Inc.
Duration
24 Weeks
Facility Type
N/A

Eligibility

Key Inclusion Criteria:

  • Male or female subject with a clinical diagnosis of AD in accordance the recommendations from the National Institute on Aging-Alzheimer's Association
  • Subject has a documented history of at least 4 months of ongoing donepezil therapy for AD, with stable dosing of 5 or 10 mg/day for at least the last 2 months and with no intent to change for the duration of the study
  • Subject has an MMSE score 12 to 24 inclusive at Screening and a Baseline MMSE score 10 to 26 inclusive. The difference between the Screening and Baseline MMSE score is less than or equal to 3 points. If a greater than 3-point difference between the Screening and Baseline MMSE score is in the opinion of the investigator due to recent changes in AD medication, Screening may be extended for an additional 3 weeks after discussion with the Medical Monitor, during which time MMSE stability, defined as less than or equal to 3-point change over 3 weeks, must be observed
  • Subject has a Hachinski Ischaemia score less than or equal to 4 at Screening
  • Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12 months before screening with findings consistent with the diagnosis of dementia due to AD without any other clinically significant pathologies
  • Age greater than or equal to 50 years to less than or equal to 85 years at the time of Screening
  • If female, subject must be:
    • Of non-childbearing potential or surgically sterile; or,
    • If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at the Screening and Baseline Visits. Female subjects of childbearing potential and who are sexually active are required to practice adequate methods of birth control. ** Male subjects who are sexually active will also be required to use an adequate form of birth control as described above
  • Subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
  • Subject must be able to ingest pills (in tablet form) whole
  • Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend visits, oversee the subject’s compliance with protocol-specified procedures and study medication, and report on subject’s status, and who has substantial contact with the subject

Key Exclusion Criteria:

  • Diagnosis of possible, probable, or definite vascular dementia in accordance with National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche l’Enseignement en Neurosciences criteria
  • History and/or evidence (including CT or MRI scan performed within the past 12 months or at Screening) of any other CNS disorder that could be interpreted as a cause of dementia (in the opinion of the investigator), e.g., cerebrovascular disease (transient ischemic attack, stroke, hemorrhage); structural or developmental abnormality; epilepsy; infectious, degenerative, or inflammatory/demyelinating CNS conditions; or Parkinson’s disease
  • Evidence of the following disorders where this is thought to be the cause of, or to contribute to the severity of, the subject’s dementia: current vitamin B12 deficiency, hypothyroidism, neurosyphilis, or Wernicke’s encephalopathy
  • Focal findings on the neurological exam (excluding changes attributable to peripheral injury) that are inconsistent with a primary diagnosis of AD
  • History of existing negative amyloid positron emission tomography scan or similar brain amyloid imaging, or Screen Failure from research trial due to negative amyloid imaging within 5 years. Note: amyloid scan is not required for participation in this study
  • Atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia, or others
  • History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness
  • Significant suicide risk
  • Current psychosis that in the opinion of the investigator would interfere with the subject’s ability to participate in this study
  • History of epilepsy or unexplained seizure in the past 5 years, unexplained recent loss of consciousness, or history of significant head trauma with loss of consciousness
  • History of malignancy during the 5 years before Screening. History of basal cell carcinoma and melanoma in situ are permitted. History of other cancers currently in a non-active state may be acceptable after review with the Medical Monitor
  • Any clinically relevant concomitant disease including progressive liver or kidney dysfunction, history of myocardial infarction or unstable angina within 6 months of Screening, history of more than 1 myocardial infarction within 5 years of Screening, history of clinically significant stroke, or any other medical or psychiatric condition, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study
  • History of alcohol use disorder or other substance abuse disorder (excluding tobacco use), according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, criteria in the past 10 years
  • History of Down syndrome or mental retardation

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Contact

Kathy Smith, RN, Research Nurse
University of South Florida - USF Health Psychiatry Center
3515 E Fletcher Ave
Tampa, FL 33613
Phone: 813-974-7006

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