A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment

Parkinson Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318937
• Other study ID #: 718-CNP-202
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2022
• Est. completion date: February 9, 2024

Study information

• Verified date: March 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 Parkinson's disease mild cognitive impairment (PD-MCI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 9, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic Parkinson's disease (PD) according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria and meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria).

2. Meet the following criteria for MoCA: For participants meeting Level 1 PD-MCI criteria, have a Montreal Cognitive Assessment (MoCA) score of 20 to 25 (inclusive) at Screening; For participants meeting Level 2 PD-MCI criteria (within the past year), have a MoCA score of 18 to 25 (inclusive) at Screening.

3. Meet criteria for modified Hoehn & Yahr Stage I to III (mild to moderate motor severity) at Screening.

4. Have stable motor symptoms for at least 4 weeks prior to Screening, in the opinion of the investigator.

5. Must be able to complete the Color Trails Test 1 (including the ability to follow rater redirection and correct errors), and, based on participant's performance and investigator's opinion, participant is expected to be capable of engaging in prolonged cognitive testing for the duration of the study.

Exclusion Criteria:

1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia with Lewy bodies, Alzheimer's dementia, and vascular dementia.

2. Have any parkinsonism other than PD, including secondary parkinsonism or atypical parkinsonism.

3. In the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with PD that will interfere with completing study procedures.

4. Have an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study.

5. Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator.

6. Have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury.

7. Have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion).

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Parkinson Disease

Intervention

Drug:
• SAGE-718
Softgel capsules
• SAGE-718-matching placebo
Softgel capsules

Locations

Country	Name	City	State
United States	Sage Investigational Site	Albany	New York
United States	Sage Investigational Site	Bloomington	Minnesota
United States	Sage Investigational Site	Boca Raton	Florida
United States	Sage Investigational Site	Boca Raton	Florida
United States	Sage Investigational Site	Burlington	Vermont
United States	Sage Investigational Site	Chicago	Illinois
United States	Sage Investigational Site	Cincinnati	Ohio
United States	Sage Investigational Site	Columbus	Ohio
United States	Sage Investigational Site	Decatur	Georgia
United States	Sage Investigational Site	Englewood	Colorado
United States	Sage Investigational Site	Fresno	California
United States	Sage Investigational Site	Hialeah	Florida
United States	Sage Investigational Site	Houston	Texas
United States	Sage Investigational Site	Kansas City	Kansas
United States	Sage Investigational Site	Las Vegas	Nevada
United States	Sage Investigational Site	Little Rock	Arkansas
United States	Sage Investigational Site	Long Beach	California
United States	Sage Investigational Site	Los Angeles	California
United States	Sage Investigational Site	Madison	Wisconsin
United States	Sage Investigational Site	Memphis	Tennessee
United States	Sage Investigational Site	Miami	Florida
United States	Sage Investigational Site	Nashville	Tennessee
United States	Sage Investigational Site	New York	New York
United States	Sage Investigational Site	Orlando	Florida
United States	Sage Investigational Site	Port Orange	Florida
United States	Sage Investigational Site	Raleigh	North Carolina
United States	Sage Investigational Site	Reseda	California
United States	Sage Investigational Site	Sacramento	California
United States	Sage Investigational Site	San Antonio	Texas
United States	Sage Investigational Site	Stony Brook	New York
United States	Sage Investigational Site	Sun City	Arizona
United States	Sage Investigational Site	Tampa	Florida
United States	Sage Investigational Site	Tampa	Florida
United States	Sage Investigational Site	Toledo	Ohio
United States	Sage Investigational Site	Vernon	Connecticut
United States	Sage Investigational Site	Virginia Beach	Virginia
United States	Sage Investigational Site	Williamsville	New York
United States	Sage Investigational Site	Woodmere	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Day 42 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score	WAIS-IV coding test is a valid and sensitive measure of cognitive dysfunction that correlates with real-world functional outcomes (e.g., the ability to accomplish everyday tasks) and recovery from functional disability used to assess processing speed. The participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The total score ranges from 0 to 135 and is based on the total number of codes correctly completed over a 120-second time limit. Higher scores indicate better processing speed. Positive change from baseline indicates better processing speed.	Baseline up to Day 42
Secondary	Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) and TEAEs by Severity		Up to Day 70
Secondary	Number of Participants who Withdraw Due to Adverse Events (AEs)		Up to Day 70