Phase 2
Completed N=26
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)
Source: ClinicalTrials.gov NCT04602624 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 7 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
7 | — |
| SECONDARY Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements |
64.0 | — |
| SECONDARY Percentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments |
12.0; 16.0 | — |
| SECONDARY Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements |
32.0 | — |
| SECONDARY Percentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) |
— | — |
Eligibility Criteria
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
- Participant has current or recent suicidality
Data sourced from ClinicalTrials.gov (NCT04602624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.