A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine
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|ClinicalTrials.gov Identifier: NCT03560245|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2018
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Bryostatin Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible subjects will be stratified based on Mini Mental State Exam (MMSE-2) scores 4-9 vs. 10-15 and will be randomized 1:1 to one of two treatment arms: 20µg bryostatin or placebo for twelve weeks (7 doses).|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Safety, Tolerability and Efficacy of Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease Subjects Not Receiving Memantine Treatment|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||July 30, 2019|
Experimental: Bryostatin 20µg
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
Placebo Comparator: Placebo
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
- Safety: Treatment emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Baseline through 30 days post end of treatment (up to Day 107) ]Incidence of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
- Efficacy: change in the Severe Impairment Battery (SIB) score obtained between the average 13 and 15-week scores and the baseline score [ Time Frame: The average of 13 and 15-week scores (Day 91 and Day 107) ]The SIB assesses cognition in subjects with moderate and severe Alzheimer's disease(AD). Test questions measure attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a total point score range of 0-100. Lower scores indicate greater cognitive impairment.
- The repeated Severe Impairment Battery (SIB) changes from the baseline SIB [ Time Frame: Weeks 5, 9, 13, and 15 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560245
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