Start: August 30, 2020
End: November 2, 2022
What Is This Study About?
This study will test whether the research drug, bryostatin, can improve cognition and slow disease progression in older adults with moderate to severe Alzheimer's disease. Participants will be randomly assigned to take seven IV injections of the study drug or placebo over 12 weeks. Thirty days later, a second treatment round will begin with another seven doses. The researchers will measure cognition at various points throughout the study with the final measurement four months after the last dose. Bryostatin affects an enzyme called protein kinase C epsilon. Activation of this enzyme is thought to improve nerve cell function and create of new connections in the brain.
Do I Qualify To Participate in This Study?
- Cognitive problems for at least two years that meet the diagnostic criteria for probable Alzheimer's dementia
- Mini-Mental State Examination score of 10 to 18
- Must have a Severe Impairment Battery score between 60 and 93
- Brain imaging, such as computerized tomography or MRI, within the last two years that is consistent with probable Alzheimer's disease
- Caregiver or study partner who spends, on average, at least three hours per day, three 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 inhibitor medications for the treatment of Alzheimer's disease must be a stable dose for at least three months and must not change during the study unless a change is required due to side effects of the prescribed medication or significant changes to the participant's health
- If prior use of memantine, must have taken the last dose at least 90 days before starting the study
- Use of antipsychotic medications must be stable for four or more weeks
- Females must be surgically sterile for at least six months, postmenopausal for one year or agree to use a double method of contraception 30 days before and after dosing, and must test negative for pregnancy
- Males must be surgically sterile or use appropriate contraception 30 days before and after dosing
- Reasonably good health over the last six months
- Any chronic disease must be stable
Must NOT have:
- Dementia due to any condition other than Alzheimer's disease, including vascular dementia
- Significant central nervous system vascular disease, including stroke, multiple brain infarcts (a small localized area of dead tissue resulting from failure of blood supply), localized single infarcts in the thalamus, angular gyrus, multiple lacunar infarcts, or extensive white matter injury in the brain
- Nervous system disease or condition other than Alzheimer's disease, such as brain tumor, chronic subdural fluid collections, Huntington's disease, Parkinson's disease, normal pressure hydrocephalus, or any other diagnosis that could interfere with determining the safety and effectiveness of the study medication
- Unstable heart, lung, kidney, liver, gastrointestinal, nervous system, or metabolic disease within the past six months
- History of cancer in the past two years; more recent history of skin cancer may be acceptable
- Creatinine clearance level of less than 45 ml 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: pethidine, levorphanol, methadone, dextropropoxyphene, tramadol, and ketobemidone
- Use of the following drugs or supplements within 14 days prior of screening: vitamin E greater than 400 IU per day, acetaminophen, gabapentin, and valproic acid
- Use of an active Alzheimer's vaccine in the past two years
- Use of a monoclonal antibody treatment of Alzheimer's disease within one year prior to screening
- Any medical or psychiatric condition that is likely to require additional medication or surgery during the course of the study
- Any laboratory test values that are determined to be clinically significant
- Any laboratory test results that suggest a different cause for dementia other than Alzheimer's disease
- Use of a research drug within 90 days prior to screening
- Active suicidal thoughts in the past six months, or suicide attempt in the past two 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 study
- Diagnosis of alcohol or drug abuse within the last two years
- Abnormal electrocardiogram
- Acute or poorly controlled medical illness, including high blood pressure greater than 180 systolic or 100 diastolic, heart attack in the past six months, or a deteriorating heart condition with symptoms such as difficulty breathing, excess fluid retention, or increasing fatigue
- Positive for HIV
- Positive for hepatitis B or C, unless successful curative treatment for hepatitis C has been received with documentation that no hepatitis B or C virus detected for at least three months after treatment
- Any blood test results that indicate abnormal liver function
- Prior exposure to bryostatin, or known sensitivity to bryostatin or any ingredient in the study drug
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Neurotrope Bioscience, Inc.
National Institute on Aging
Source: ClinicalTrials.gov ID: NCT04538066