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)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2021-09-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Alzheimer Disease Cognitive Dysfunction Mild Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAGE-718

Participants received SAGE-718 3 mg oral tablets, once daily in the morning for 14 days.

Group Type EXPERIMENTAL

SAGE-718

Intervention Type DRUG

SAGE-718 oral tablets.

Interventions

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SAGE-718

SAGE-718 oral tablets.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No