A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease (NCT02431468) | Clinical Trial Compass
CompletedPhase 2
A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease
United States147 participantsStarted 2015-11
Plain-language summary
This is a randomized double-blind placebo-controlled study comparing different doses of bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug.
Who can participate
Age range55 Years – 85 Years
SexALL
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Inclusion Criteria:
* Written informed consent from caregiver and subject (if possible) or legally acceptable representative if different from caregiver
* Male and female subjects 55-85 years of age inclusive
* Cognitive deficit present for at least 2 years that meet the diagnostic criteria for probable Alzheimer's
* Mini Mental State Exam (MMSE-2) score of 4-15
* Patients must be able to perform at least one item on the Severe Impairment Battery Scale
* Neuroimaging (computerized tomography (CT) or Magnetic Resonance Imaging (MRI)) within the last 24 months consistent with a diagnosis of probable Alzheimer's disease (AD)
* Reliable caregiver(s) or informant(s) who attends the subject at least an average of 3 hours or more per day for 3 or more days per week
* Adequate vision and motor function to comply with testing
* If taking drugs approved for treatment of Alzheimer's disease (e.g. cholinesterase inhibitors, memantine), must be on a stable dose for at least 3 months prior to entry into study and the dose must not change during the study unless a change is required due to an adverse event or a clinically significant change in the patient's status.
Exclusion Criteria:
* Dementia due to any condition other than AD, including vascular dementia (Rosen-modified Hachinski lschemic score ≥ 5)
* Evidence of significant central nervous system (CNS) vascular disease on previous neuroimaging including but not limited to: cortical stroke, multiple infarcts, localized single infarct…
What they're measuring
1
Safety: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events
Timeframe: Baseline through 30 days post end of treatment (up to Day 107)
2
Efficacy: Change From Baseline in Severe Impairment Battery (SIB) in the Full Analysis Set (FAS)
Timeframe: Primary analysis at Week 13 (day 91) after 12 weeks of treatment (up to day 107)