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Trial record 2 of 11 for:    SAGE-718
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602624
Recruitment Status : Completed
First Posted : October 26, 2020
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Cognitive Dysfunction Mild Dementia Drug: SAGE-718 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2021
Actual Primary Completion Date : September 21, 2021
Actual Study Completion Date : September 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SAGE-718
Participants will receive a single dose of SAGE-718 oral tablets, once daily in the morning for 14 days.
 Drug: SAGE-718
SAGE-718 oral tablets.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to Day 28 ]
    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 :
  1. Percentage of Participants With Clinically Significant Changes in Vital Signs Measurements [ Time Frame: Up to Day 28 ]
  2. Percentage of Participants With Clinically Significant Changes in Laboratory Assessments [ Time Frame: Up to Day 28 ]
  3. Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements [ Time Frame: Up to Day 28 ]
  4. Percentage of Participants With Change From Baseline Responses on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to Day 28 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602624


Locations
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United States, Arizona
Sage Investigational Site
Phoenix, Arizona, United States, 85044
United States, California
Sage Investigational Site
Redlands, California, United States, 92374
United States, Florida
Sage Investigational Site
Miami, Florida, United States, 33137
Sage Investigational Site
Saint Petersburg, Florida, United States, 33713
United States, Georgia
Sage Investigational Site
Decatur, Georgia, United States, 30030
Sage Investigational Site
Decatur, Georgia, United States, 30033
United States, Maryland
Sage Investigational Site
Gaithersburg, Maryland, United States, 20877
United States, Michigan
Sage Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, Nebraska
Sage Investigational Site
Omaha, Nebraska, United States, 68130
United States, Ohio
Sage Investigational Site
North Canton, Ohio, United States, 44720
Sponsors and Collaborators
Sage Therapeutics
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT04602624    
Other Study ID Numbers: 718-CNA-201
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders