A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

This is a randomized double-blind placebo-controlled study comparing different doses of bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug.

Key facts

Study ID

NCT02431468

Run by

Neurotrope Bioscience, Inc.

People needed

147

Starts

2015-11-01

Expected to finish

2017-02-01

Last updated by the study team

2018-07-06

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Mini Mental State Exam (MMSE-2) score of 4-15
• Patients must be able to perform at least one item on the Severe Impairment Battery Scale
• Neuroimaging (computerized tomography (CT) or Magnetic Resonance Imaging (MRI)) within the last 24 months consistent with a diagnosis of probable Alzheimer's disease (AD)
• 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
• Adequate vision and motor function to comply with testing
• If taking drugs approved for treatment of Alzheimer's disease (e.g. cholinesterase inhibitors, memantine), 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 event or a clinically significant change in the patient's status.

You may not qualify if…

• Dementia due to any condition other than AD, including vascular dementia (Rosen-modified Hachinski lschemic score ≥ 5)
• Evidence of significant central nervous system (CNS) vascular disease on previous neuroimaging including but not limited to: cortical stroke, multiple infarcts, localized single infarcts in the thalamus, angular gyrus, multiple lacunar infarcts or extensive white matter injury
• Clinically significant neurologic disease or condition other than AD, 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
• Evidence of clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within the 6 months prior to enrollment
• Poorly controlled diabetes, at the discretion of the Principal Investigator
• Creatinine clearance (CL) of <45ml/min
• Use of an active Alzheimer's vaccine within 2 years prior to screening
• Use of a monoclonal antibody for treatment of AD within 1 year prior to screening
• Any medical or psychiatric condition that is likely to require initiation of additional medication or surgical intervention during the course of the study
• Use of an investigational drug within 30 days prior to screening
• Prior exposure to bryostatin, or known sensitivity to bryostatin or any ingredient in the study drug
• Any other concurrent medical condition, which in the opinion of the PI makes the subject unsuitable for the clinical study

Where it is running

• Xenoscience, Inc/ 21st Century Neurology — Phoenix, Arizona, United States
• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• Nader Pharmacology Research Institute — Los Alamitos, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• JEM Research — Atlantis, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of South Florida — Fort Myers, Florida, United States
• Alzheimer's Research and Treatment Center — Lake Worth, Florida, United States
• Miami Jewish Health System — Miami, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Compass Research — The Villages, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Alexian Brothers Neurosciences Institute Clinical Research — Elk Grove Village, Illinois, United States
• University of Kansas Alzheimer's Disease Center — Fairway, Kansas, United States
• Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
• J. Gary Booker, MD APMC Clinical Drug Trials — Shreveport, Louisiana, United States
• Millennium Psychiatric Associates — Creve Coeur, Missouri, United States
• Atlantic Neuroscience Institute — Springfield, New Jersey, United States
• Neurological Associates of Albany, PC — Albany, New York, United States
• Parker Jewish Institute for Health Care and Rehabilitation — New Hyde Park, New York, United States
• Alzheimer's Memory Center — Charlotte, North Carolina, United States
• Neurobehavioral Clinical Research — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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