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Find more clinical trials

Bryostatin for Moderate to Severe Alzheimer's Disease

Start: June 20, 2018
End: July 2019
Enrollment: 100

What Is This Study About?

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).

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 85 Years

Must have:

  • 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

Must NOT have:

  • 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

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?

Who Sponsors This Study?

Lead: Neurotrope Bioscience, Inc.

Collaborator Sponsor

  • Worldwide Clinical Trials

Source: ClinicalTrials.gov ID: NCT03560245

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health