A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Assessing Safety, Tolerability, and Efficacy of Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer’s Disease

Autor: Richard E. Thompson, Elaine Grenier, Alan J. Tuchman, Martin R. Farlow, Susanne Wilke, Jeffrey Benison, Lee-Jen Wei, David Crockford, Daniel L. Alkon
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Male
Phases of clinical research
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Cognition
Activities of Daily Living
Clinical endpoint
Medicine
Bryostatin
Infusions
Intravenous
Aged
80 and over
synaptogenesis
severe Alzheimer’s disease
General Neuroscience
Memantine
General Medicine
Middle Aged
Bryostatins
Mental Status and Dementia Tests
neurorestorative
Psychiatry and Mental health
Clinical Psychology
Treatment Outcome
Tolerability
Cohort
Female
medicine.drug
Research Article
medicine.medical_specialty
Patient Dropouts
Placebo
03 medical and health sciences
Double-Blind Method
Alzheimer Disease
Internal medicine
Humans
Dosing
Aged
Dose-Response Relationship
Drug
business.industry
synaptic growth factors
PKC (Protein Kinase C)
030104 developmental biology
chemistry
severe impairment battery
memantine
Geriatrics and Gerontology
business
Negative Results
030217 neurology & neurosurgery
Zdroj: Journal of Alzheimer's Disease
ISSN: 1875-8908
1387-2877
Popis: Background: Bryostatin-activated PKC epsilon pre-clinically induces synaptogenesis, anti-apoptosis, anti-amyloid-β oligomers, and anti-hyperphosphorylated tau. Objectives: To investigate bryostatin safety, tolerability, and efficacy to improve cognition in advanced Alzheimer’s disease (AD) patients. Methods: A double-blind, randomized, placebo-controlled Phase II, 12-week trial of i.v. bryostatin for 150 advanced AD patients (55–85) with MMSE-2 of 4–15, randomized 1:1:1 into 20 μg and 40 μg bryostatin, and placebo arms. The Full Analysis Set (FAS) and the Completer Analysis Set (CAS) were pre-specified alternative assessments (1-sided, p
Databáze: OpenAIRE
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