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Trial record 2 of 11 for:    SAGE-718

A Study to Evaluate the Effects 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. Identifier: NCT05619692
Recruitment Status : Active, not recruiting
First Posted : November 17, 2022
Last Update Posted : April 22, 2024
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Mild Dementia Alzheimer's Disease Drug: SAGE-718 Drug: SAGE-718-matching Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
Actual Study Start Date : December 27, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SAGE-718
Participants will receive 1.2mg of SAGE-718 orally once daily for the first 6 weeks Days 1 to 42 [±2 days], followed by 0.9 mg of SAGE-718 for the remainder of the Treatment period up to Day 84 Visit [±7 days].
Drug: SAGE-718
Softgel lipid capsules.

Placebo Comparator: Placebo
Participants will receive placebo-matching capsule once daily orally throughout the treatment period for up to Day 84.
Drug: SAGE-718-matching Placebo
Softgel lipid capsules.

Primary Outcome Measures :
  1. Change from Baseline in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test [ Time Frame: Baseline to Day 84 ]
    The WAIS-IV Coding Test is a valid and sensitive measure of cognitive dysfunction. Administration of the WAIS-IV Coding Test will use the traditional paper-and-pen format, in which the participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The score will be based on the total number of codes correctly completed over a 120-second time limit.

Secondary Outcome Measures :
  1. Percentage of Participants With At least One or More Treatment-emergent Adverse Events (TEAEs) and by Severity [ Time Frame: From the inform consent signing up to end of the study (Up to approximately Day 119) ]
    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

  2. Number of Participants Who Withdraw Due to Adverse Events (AEs) [ Time Frame: From the inform consent signing up to end of the study (Up to approximately Day 119) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  1. Meet the following criteria for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) at Screening:

    1. A memory complaint reported by the participant or their study partner
    2. A Clinical Dementia Rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5
    3. Essentially preserved activities of daily living, in the opinion of the investigator
    4. Brain Magnetic Resonance Imaging (MRI) report, obtained within the 2 years preceding the Baseline Period, that is consistent with the diagnosis of AD with no clinically significant findings of non-AD pathology that could account for the observed cognitive impairment
  2. Have a score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) with years of education adjustment at Screening.

Exclusion Criteria:

  1. Have participated in a previous clinical study of SAGE-718, have participated in a previous gene therapy study, or have received study treatment in any other drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer), unless the participant participated solely in the placebo arm of the study. Additionally, participants who have received treatment with antisense oligonucleotides (ASO) will be excluded
  2. Have a condition that precludes undergoing an MRI, in accordance with standard operating procedures at the imaging facility (eg, ferromagnetic metal in the body, claustrophobia), in a participant requiring MRI during Screening
  3. Have any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline
  4. Have a history, presence, and/or current evidence of

    1. Brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury
    2. Possible or probable cerebral amyloid angiopathy, according to the Boston Criteria
    3. Treatment with an anti-amyloid therapy (including biologics) without subsequent MRI demonstrating the absence of amyloid-related imaging abnormalities
    4. Seizures or epilepsy, with the exception of childhood febrile seizures
  5. Participants has a history of suicidal behavior within 2 years or answers "YES" to Questions 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or at Day 1 or is currently at risk of suicide in the opinion of the investigator
  6. Have any of the following medical conditions:

    1. Any clinically significant finding on 12-lead electrocardiogram (ECG) during Screening in the opinion of the investigator
    2. Any clinically significant supine vital signs (heart rate, systolic and diastolic blood pressure) during Screening (note: vital sign measurements may be repeated once)
  7. Have a history, presence, and/or current evidence of serologic positive results for human immunodeficiency virus (HIV)-1 or HIV-2, or hepatitis B or C
  8. Have a positive pregnancy test, or be lactating, or intend to breastfeed during the study
  9. Is known to be allergic to any of SAGE-718 excipients, including soy lecithin

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 identifier (NCT number): NCT05619692

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United States, Arizona
Sage Investigational Site
Gilbert, Arizona, United States, 85297
Sage Investigational Site
Phoenix, Arizona, United States, 85297
United States, California
Sage Investigational Site
Lafayette, California, United States, 94549
Sage Investigational Site
Long Beach, California, United States, 90808
Sage Investigational Site
Redlands, California, United States, 92374
Sage Investigational Site
San Diego, California, United States, 92123
Sage Investigational Site
Sherman Oaks, California, United States, 91403
United States, Colorado
Sage Investigational Site
Englewood, Colorado, United States, 80120
United States, Florida
Sage Investigational Site
Hollywood, Florida, United States, 33024
Sage Investigational Site
Jacksonville, Florida, United States, 32256
Sage Investigational Site
Miami, Florida, United States, 33155
Sage Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Sage Investigational Site
Pensacola, Florida, United States, 32504
Sage Investigational Site
Tampa, Florida, United States, 33609
Sage Investigational Site
Winter Park, Florida, United States, 32789
United States, Georgia
Sage Investigational Site
Decatur, Georgia, United States, 30030
Sage Investigational Site
Savannah, Georgia, United States, 31404
United States, Idaho
Sage Investigational Site
Meridian, Idaho, United States, 83642
United States, Illinois
Sage Investigational Site
Chicago, Illinois, United States, 60640
United States, Massachusetts
Sage Investigational Site
Charlestown, Massachusetts, United States, 02129
Sage Investigational Site
Methuen, Massachusetts, United States, 01844
United States, Missouri
Sage Investigational Site
Chesterfield, Missouri, United States, 63005
United States, Nebraska
Sage Investigational Site
Papillion, Nebraska, United States, 68046
United States, New Jersey
Sage Investigational Site
Toms River, New Jersey, United States, 08755
United States, New Mexico
Sage Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Sage Investigational Site
Brooklyn, New York, United States, 11229
Sage Investigational Site
Buffalo, New York, United States, 14203
Sage Investigational Site
Staten Island, New York, United States, 10312
United States, North Carolina
Sage Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Sage Investigational Site
Abington, Pennsylvania, United States, 19001
United States, Tennessee
Sage Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Sage Investigational Site
Austin, Texas, United States, 78731
Sage Investigational Site
Dallas, Texas, United States, 75231
Sage Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Sage Investigational Site
Fairfax, Virginia, United States, 22031
Puerto Rico
Sage Investigational Site
Bayamon, Puerto Rico, 00961
Sponsors and Collaborators
Sage Therapeutics
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Responsible Party: Sage Therapeutics Identifier: NCT05619692    
Other Study ID Numbers: 718-CNA-202
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of

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