Last updated on February 2016

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alzheimer's Disease
  • Age: Between 50 - 85 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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