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)

NCT04602624 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 718-CNA-201
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Alzheimer Disease; Cognitive Dysfunction; Mild Dementia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

  From first dose of study drug up to last follow up visit (up to 28 days)

Secondary Outcomes (4)

• Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements

  From first dose of study drug up to last follow-up visit (up to 28 days)

• Percentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments

  From first dose of study drug up to last follow-up visit (up to 28 days)

• Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements

  From first dose of study drug up to last follow-up visit (up to 28 days)

• Percentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

  Up to Day 28

Study Arms (1)

SAGE-718

EXPERIMENTAL

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

Drug: SAGE-718

Interventions

SAGE-718 DRUG

SAGE-718 oral tablets.

SAGE-718

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (10)

Sage Investigational Site

Phoenix, Arizona, 85044, United States

Location

Sage Investigational Site

Redlands, California, 92374, United States

Location

Sage Investigational Site

Miami, Florida, 33137, United States

Location

Sage Investigational Site

St. Petersburg, Florida, 33713, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Decatur, Georgia, 30033, United States

Location

Sage Investigational Site

Gaithersburg, Maryland, 20877, United States

Location

Sage Investigational Site

Farmington Hills, Michigan, 48334, United States

Location

Sage Investigational Site

Omaha, Nebraska, 68130, United States

Location

Sage Investigational Site

North Canton, Ohio, 44720, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Medical Monitor
• Organization: Sage Therapeutics

info@sagerx.com

(617) 299-8380

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: December 7, 2020
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: September 15, 2025
• Results First Posted: October 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)