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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)

Primary Purpose

Alzheimer Disease, Cognitive Dysfunction, Mild Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SAGE-718
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAGE-718

Arm Description

Participants will receive a single dose of SAGE-718 oral tablets, once daily in the morning for 14 days.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that occurs after the first administration of a study drug.

Secondary Outcome Measures

Percentage of Participants With Clinically Significant Changes in Vital Signs Measurements
Percentage of Participants With Clinically Significant Changes in Laboratory Assessments
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Percentage of Participants With Change From Baseline Responses on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS scale consists of a baseline evaluation that assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).

Full Information

First Posted
October 20, 2020
Last Updated
September 21, 2022
Sponsor
Sage Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04602624
Brief Title
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)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Dysfunction, Mild Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAGE-718
Arm Type
Experimental
Arm Description
Participants will receive a single dose of SAGE-718 oral tablets, once daily in the morning for 14 days.
Intervention Type
Drug
Intervention Name(s)
SAGE-718
Intervention Description
SAGE-718 oral tablets.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that occurs after the first administration of a study drug.
Time Frame
Up to Day 28
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinically Significant Changes in Vital Signs Measurements
Time Frame
Up to Day 28
Title
Percentage of Participants With Clinically Significant Changes in Laboratory Assessments
Time Frame
Up to Day 28
Title
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Time Frame
Up to Day 28
Title
Percentage of Participants With Change From Baseline Responses on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS scale consists of a baseline evaluation that assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).
Time Frame
Up to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sage Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Sage Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Sage Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Sage Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Sage Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Sage Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Sage Investigational Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Sage Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Sage Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Sage Investigational Site
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Learn more about this trial

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)

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