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About
This is a randomized double-blind Placebo-controlled, Phase 2 study comparing bryostatin to placebo for the treatment of moderately severe to severe Alzheimer's disease in subjects not receiving memantine treatment. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug. Subjects will receive 7 doses of study drug during the study. The primary efficacy endpoint is defined as the change from baseline to Week 13 in the Severe Impairment Battery (SIB) total score.
Full 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. The first two doses of study drug will be a loading dose 20% higher (i.e., 24µg) than the assigned dose and will be administered one week apart. Thereafter, the assigned dose of 20µg will commence with the third dose and be administered every other week. Drug is administered IV by continuous infusion over 45(±5) minutes. Subjects are scheduled to receive seven doses over 12 weeks.
Enrollment
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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 dementia. The diagnosis must be confirmed at the time of the screening visit
MMSE-2 score of 4-15 inclusive (applies to Screening Visit only)
Patients must be able to perform at least one item on the SIB and may not have a SIB score >93 at screening
Neuroimaging computerized tomography (CT) or Magnetic Resonance Imaging (MRI) within the last 24 months consistent with a diagnosis of probable AD without any other clinically significant co-morbid pathologies. If there has been a significant change in the subject's clinical status since the last imaging study that is not consistent with progression of the subject's AD, an imaging study should be performed to confirm eligibility
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 and who will agree to accompany the subject to the clinic visits and reliably complete the caregiver questions
Adequate vision and motor function to comply with testing
If taking an approved cholinesterase inhibitor for treatment of Alzheimer's disease, 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 effect of the prescribed medication or a clinically significant change in the patient's status
Subjects who are memantine naïve or have been off memantine for at least 30 days prior to initial treatment with study drug
Subjects on neuroleptic medications must be on a stable dose for ≥4 weeks (dose adjustments will be permitted)
Females participating in the study must meet one the following criteria:
Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) from 30 days prior to dosing until 30 days after last dose
In the opinion of the PI subjects should be in reasonably good health over the last 6 months and any chronic disease should be stable -
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
108 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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