Conditions: Alzheimer's Disease
Keywords: Alzheimer's bryostatin PKC epsilon
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
This study is being done to evaluate the safety, tolerability and potential effectiveness of a new investigational drug, bryostatin 1, in patients with Alzheimer's disease (AD).

Detailed description:
This study is a single center, randomized, double-blind, placebo-controlled, parallel groups trial in patients with AD. Each subject enrolled in the trial will be randomized to receive a single IV dose of 0 (placebo) or 25 μg/m2 bryostatin. A total of 15 subjects (5 in the placebo arm and 10 in the treatment arm) will be enrolled in the study. The study consists of screening evaluations and on study evaluations divided into two segments, an inpatient segment and an outpatient segment. The four-day inpatient segment will consist of baseline evaluations and a 1-hour IV infusion of study drug followed by evaluations at multiple evaluations over the first 72 hrs post dose. During the outpatient segment, patients will be followed for AEs and have a final evaluation at 2 weeks post dose and a 4-week telephone safety follow up. Evaluations will include safety, efficacy, pharmacokinetics, and pharmacodynamics as assessed by PKC activity

Arms:
arm 1: single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour arm 2: single dose of placebo, intravenous infusion over 1 hour

Interventions: intervention 1: Bryostatin 1 intervention 2: Placebo
Intervention descriptions: intervention 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour. intervention 2: Placebo, single dose via intravenous infusion over 1 hour.

Protocol document: