A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive I… (NCT04602624) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
United States26 participantsStarted 2020-12-07
Plain-language summary
The primary purpose of this study is to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive and neuropsychiatric symptoms in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD).
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. Participant meets the following criteria for MCI or mild dementia due to AD at Screening: has a memory complaint, has clinical dementia rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5, has essentially preserved activities of daily living
✓. Participant has a score of 15 to 24 (inclusive) on the Montreal Cognitive Assessment at Screening
✓. Participant has normal premorbid intelligence quotient (IQ) at Screening
✓. Participant has a study partner who is reliable, competent, at least 18 years of age, willing to be available to the study center by phone, support study-specific activities, and accompany the participant to study visits as needed
Exclusion criteria
✕. Participant has any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline
✕. Participant has a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury
✕. Participant has a history, presence, and/or current evidence of a clinically-significant intracranial abnormality (eg, stroke, hemorrhage, space-occupying lesion) that could account for the observed cognitive impairment (excluding abnormalities consistent with underlying AD pathology)
✕. Participant has a history of possible or probable cerebral amyloid angiopathy, according to the Boston Criteria
✕. Participant has a history of seizures or epilepsy, with the exception of a single episode of febrile seizures in childhood
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose of study drug up to last follow up visit (up to 28 days)