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Bryostatin for Moderate to Severe Alzheimer's Disease

Completed

This Phase II study will test the investigational drug bryostatin as a treatment for moderate to severe Alzheimer's disease in older adults not receiving memantine (Namenda or Namzaric).

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years All No
June 20, 2018
July 25, 2019
100

  • Cognitive deficit for at least 2 years that meets the criteria for probable Alzheimer's dementia
  • Mini-Mental State Examination score of 4 to 15
  • Must be able to perform at least one item on the Severe Impairment Battery (SIB) scale and may not have an SIB score greater than 97
  • Computerized tomography or magnetic resonance imaging in past 2 years consistent with probable Alzheimer's disease
  • Caregiver or informant who spends, on average, at least 3 hours per day, 3 or more days per week, with the participant and can attend clinic visits and complete caregiver questions
  • Adequate vision and motor function to complete testing
  • Use of cholinesterase inhibitorsRazadyne (galantamine), Exelon (rivastigmine), or Aricept (donepezil)for Alzheimer's disease must be stable dose for at least 3 months
  • Not taking memantine for at least 30 days prior to initial treatment with study drug
  • Use of neuroleptic medications must be stable for 4 or more weeks
  • Females must be surgically sterile for at least 6 months, postmenopausal for 1 year, or agree to use a double method of contraception 30 days before and after dosing (must not be pregnant)
  • Males must be surgically sterile or use appropriate contraception 30 days before and after dosing
  • Reasonably good health over the last 6 months
  • Any chronic disease must be stable

  • Dementia due to any condition other than Alzheimer's disease, including vascular dementia
  • Evidence of significant central nervous system vascular disease, including cortical stroke, multiple infarcts, localized single infarcts in the thalamus, angular gyrus, multiple lacunar infarcts, or extensive white matter injury
  • Neurologic disease or condition other than Alzheimer's, such as cerebral tumor, chronic subdural fluid collections, Huntington's disease, Parkinson's disease, normal pressure hydrocephalus, or any other diagnosis that could interfere with assessment of safety and efficacy
  • Unstable heart, lung, kidney, liver, gastrointestinal, neurologic, or metabolic disease within past 6 months
  • Creatinine clearance level of less than 45 milliliters per minute
  • Poorly controlled diabetes
  • Prohibited medications: NMDA receptor antagonists, including memantine or drug combinations containing memantine, dextromethorphan (a cough suppressant), ketamine, phencyclidine, methoxetamine, nitrous oxide, and the following synthetic opioids: penthidine, levorphanol, methadone, dextropropoxyphene, tramadol, and ketobemidone
  • Use of vitamin E greater than 400 international units per day within 14 days prior to screening
  • Use of valproic acid within 14 days prior to screening
  • Use of an active Alzheimer's vaccine within 2 years or a monoclonal antibody for Alzheimer's within 1 year prior to screening
  • Any medical or psychiatric condition that is likely to require additional medication or surgical intervention during the study
  • Any laboratory values deemed clinically significant
  • Use of an investigational drug within 30 days prior to screening
  • Active suicidal thoughts in past 6 months or suicide attempt in past 2 years
  • Major psychiatric illness such as current major depression, current or past diagnosis of bipolar disorder, schizophrenia, or any other psychiatric disorder that might interfere with the assessments of safety or efficacy
  • Diagnosis of alcohol or drug abuse within the last 2 years
  • History of prolonged QT or prolonged QT on screening electrocardiogram
  • Acute or poorly controlled medical illness (blood pressure greater than 180 systolic or 100 diastolic, heart attack in past 6 months, or uncompensated congestive heart failure)
  • Positive for HIV or hepatitis B or C, unless successful curative treatment for hepatitis C has been received
  • Abnormal values on liver blood tests (AST or ALT greater than 3 times the upper limit of normal), total bilirubin levels greater than 2 times the upper limit of normal, or international normalized ratio greater than 1.5
  • Prior exposure to bryostatin, or known sensitivity to bryostatin or any ingredient in the study drug

Bryostatin-1 is being investigated for its ability to improve cognition and stop disease progression in people with Alzheimer's disease. Participants will be randomly assigned to take either seven doses of the study drug or placebo over 12 weeks via 45-minute intravenous infusions. The first two doses of the study drug will be 24 g (micrograms) administered weekly, followed by 20 g administered every other week.

Name City State Zip Status Primary Contact
Neuro Pain Medical Center
Fresno California 93710

Nader Pharmacology Research Institute
Los Alamitos California 90720

Syrentis Clinical Research
Santa Ana California 92705

Southern California Research, LLC
Simi Valley California 93065

JEM Research
Atlantis Florida 33462

Brain Matters Research
Delray Beach Florida 33445

MD Clinical
Hallandale Beach Florida 33009

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449

Miami Jewish Health / Stein Gerontological Institute
Miami Florida 33137

Phoenix Medical Research
Miami Florida 33165

Miami Dade Medical Research Institute, LLC
Miami Florida 33176

Medical Research Group of Central Florida
Orange City Florida 32763

Bioclinica Research
Orlando Florida 32806

Anchor Neuroscience
Pensacola Florida 32502

Stedman Clinical Trials
Tampa Florida 33613

Bioclinica Research
The Villages Florida 32162

Atlanta Center for Medical Research
Atlanta Georgia 30331

Medical Research & Health Education Foundation
Columbus Georgia 31909

Alexian Brothers Neuroscience Institute
Elk Grove Village Illinois 60007

Lake Charles Clinical Trials
Lake Charles Louisiana 70629

Alzheimer's Disease Center
Quincy Massachusetts 02169

Millennium Psychiatric Associates
Creve Coeur Missouri 63141

The Cognitive and Research Center of New Jersey
Springfield New Jersey 07801

Neurological Associates of Albany, PC
Albany New York 12208

Burke Rehabilitation Hospital
White Plains New York 10605

Alzheimer's Memory Center
Charlotte North Carolina 28270

Insight Clinical Trials, LLC
Shaker Heights Ohio 44122

Memory Health Center at Summit Research Network
Portland Oregon 97210

Neurotrope Bioscience, Inc.

  • Worldwide Clinical Trials

Name Phone Email
David Crockford 973-242-0005 dcrockford@neurotrope.com
Elaine Grenier 973-242-0005 egrenier@neurotrope.com

NCT03560245

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