A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05619692
• Other study ID #: 718-CNA-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 27, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Mild Dementia

Intervention

Drug:
• SAGE-718
Softgel lipid capsules.
• SAGE-718-matching Placebo
Softgel lipid capsules.

Locations

Country	Name	City	State
Puerto Rico	Sage Investigational Site	Bayamon
United States	Sage Investigational Site	Abington	Pennsylvania
United States	Sage Investigational Site	Albuquerque	New Mexico
United States	Sage Investigational Site	Austin	Texas
United States	Sage Investigational Site	Brooklyn	New York
United States	Sage Investigational Site	Buffalo	New York
United States	Sage Investigational Site	Charlestown	Massachusetts
United States	Sage Investigational Site	Chesterfield	Missouri
United States	Sage Investigational Site	Chicago	Illinois
United States	Sage Investigational Site	Dallas	Texas
United States	Sage Investigational Site	Decatur	Georgia
United States	Sage Investigational Site	Englewood	Colorado
United States	Sage Investigational Site	Fairfax	Virginia
United States	Sage Investigational Site	Gilbert	Arizona
United States	Sage Investigational Site	Hollywood	Florida
United States	Sage Investigational Site	Houston	Texas
United States	Sage Investigational Site	Jacksonville	Florida
United States	Sage Investigational Site	Lafayette	California
United States	Sage Investigational Site	Long Beach	California
United States	Sage Investigational Site	Memphis	Tennessee
United States	Sage Investigational Site	Meridian	Idaho
United States	Sage Investigational Site	Methuen	Massachusetts
United States	Sage Investigational Site	Miami	Florida
United States	Sage Investigational Site	Palm Beach Gardens	Florida
United States	Sage Investigational Site	Papillion	Nebraska
United States	Sage Investigational Site	Pensacola	Florida
United States	Sage Investigational Site	Phoenix	Arizona
United States	Sage Investigational Site	Raleigh	North Carolina
United States	Sage Investigational Site	Redlands	California
United States	Sage Investigational Site	San Diego	California
United States	Sage Investigational Site	Savannah	Georgia
United States	Sage Investigational Site	Sherman Oaks	California
United States	Sage Investigational Site	Staten Island	New York
United States	Sage Investigational Site	Tampa	Florida
United States	Sage Investigational Site	Toms River	New Jersey
United States	Sage Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test	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.	Baseline to Day 84
Secondary	Percentage of Participants With At least One or More Treatment-emergent Adverse Events (TEAEs) and by Severity	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.	From the inform consent signing up to end of the study (Up to approximately Day 119)
Secondary	Number of Participants Who Withdraw Due to Adverse Events (AEs)		From the inform consent signing up to end of the study (Up to approximately Day 119)