← Trials/Trial dossier/NCT04602624
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)
An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
Lead sponsor
Asset
SAGE-718
Listed sites
10
Recruiting sites
-
Enrollment
26
actual
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criteria
•Alzheimer's disease•MoCA 15-24•Study partner/caregiver required
Primary endpoint
•Treatment-Emergent Adverse Events (TEAEs)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 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
2. Participant has a score of 15 to 24 (inclusive) on the Montreal Cognitive Assessment at Screening
3. Participant has normal premorbid intelligence quotient (IQ) at Screening
4. 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
1. 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
2. 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
3. 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)
4. Participant has a history of possible or probable cerebral amyloid angiopathy, according to the Boston Criteria
5. Participant has a history of seizures or epilepsy, with the exception of a single episode of febrile seizures in childhood
6. Participant has current or recent suicidality
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Behavior / neuropsychiatric
2 endpointsPercentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame:Up to Day 28
threshold achievement, improvement
Percentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame:Up to Day 28
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | Reported bounds |
|---|---|---|
| SAGE-718n=26 Participants | 0 | - |
Safety / tolerability / PK
6 endpointsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame:From first dose of study drug up to last follow up visit (up to 28 days)
event count, event
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame:From first dose of study drug up to last follow up visit (up to 28 days)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| SAGE-718n=26 Participants | 7 | - |
Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements
Time frame:From first dose of study drug up to last follow-up visit (up to 28 days)
change from baseline, event
Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements
Time frame:From first dose of study drug up to last follow-up visit (up to 28 days)
change from baseline, event
Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements
Time frame:From first dose of study drug up to last follow-up visit (up to 28 days)
change from baseline, event
Posted result
| Group | Value (number), percentage of participants | Reported bounds |
|---|---|---|
| SAGE-718n=25 Participants | 64.0 | - |
Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements
Time frame:From first dose of study drug up to last follow-up visit (up to 28 days)
change from baseline, event
Posted result
| Group | Value (number), percentage of participants | Reported bounds |
|---|---|---|
| SAGE-718n=25 Participants | 32.0 | - |
Other (unclassified)
2 endpointsPercentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments
Time frame:From first dose of study drug up to last follow-up visit (up to 28 days)
change from baseline, improvement
Percentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments
Time frame:From first dose of study drug up to last follow-up visit (up to 28 days)
change from baseline, improvement
Posted result
| Group | Value (number), percentage of participants | Reported bounds |
|---|---|---|
| SAGE-718Hematologyn=25 Participants | 12.0 | - |
| Biochemistryn=25 Participants | 16.0 | - |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.