A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine (NCT03560245) | Clinical Trial Compass
CompletedPhase 2
A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine
United States108 participantsStarted 2018-06-20
Plain-language summary
This is a randomized double-blind Placebo-controlled, Phase 2 study comparing bryostatin to placebo for the treatment of moderately severe to severe Alzheimer's disease in subjects not receiving memantine treatment. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug. Subjects will receive 7 doses of study drug during the study. The primary efficacy endpoint is defined as the change from baseline to Week 13 in the Severe Impairment Battery (SIB) total score.
Who can participate
Age range55 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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 dementia. The diagnosis must be confirmed at the time of the screening visit
✓. MMSE-2 score of 4-15 inclusive (applies to Screening Visit only)
✓. Patients must be able to perform at least one item on the SIB and may not have a SIB score \>93 at screening
✓. Neuroimaging computerized tomography (CT) or Magnetic Resonance Imaging (MRI) within the last 24 months consistent with a diagnosis of probable AD without any other clinically significant co-morbid pathologies. If there has been a significant change in the subject's clinical status since the last imaging study that is not consistent with progression of the subject's AD, an imaging study should be performed to confirm eligibility
✓. 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 and who will agree to accompany the subject to the clinic visits and reliably complete the caregiver questions
✓. Adequate vision and motor function to comply with testing
Exclusion criteria
✕. Dementia due to any condition other than AD, including vascular dementia (Rosen-Modified Hachinski Ischemic score ≥ 5)
Timeframe: Baseline through 30 days post end of treatment (up to Day 107)
2
Efficacy: The Primary Efficacy Endpoint is Defined as the Change From Baseline to Week 13 in the Severe Impairment Battery (SIB) Total Score in the Full Analysis Set
Timeframe: The change in the SIB Total Score from baseline to Week 13 (Day 91)
. 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. . If there is a history of cancer the subject should be clear of cancer for at least 2 years prior to screening. More recent history of basal cell or squamous cell carcinoma and melanoma in situ (Stage 0) may be acceptable after review by the Medical Monitor.
✕. Creatinine clearance (CL) of \<45ml/min
✕. Poorly controlled diabetes, at the discretion of the Principal Investigator
✕. Concomitant treatment with NMDA receptor antagonists such as but not limited to memantine or drug combinations containing memantine, dextromethorphan (a cough suppressant), ketamine, phencyclidine (PCP), methoxetamine (MXE), nitrous oxide (N2O) and the following synthetic opioids: penthidine, levorphanol, methadone, dextropropoxyphene, tramadol, and ketobemidone.
✕. Use of vitamin E \> 400 International Units (IU) per day within 14 days prior to screening