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

Sponsor
Sage Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05318937
Collaborator
(none)
76
6
2
13.9
12.7
0.9

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 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 Parkinson's Disease Cognitive Impairment
Actual Study Start Date :
Jul 6, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SAGE-718

Participants will receive SAGE-718 capsules, orally, once daily in the morning for 42 days.

Drug: SAGE-718
Softgel capsules

Placebo Comparator: Placebo

Participants will receive SAGE-718-matching placebo capsules, orally, once daily in the morning for 42 days.

Drug: SAGE-718-matching placebo
Softgel capsules

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline to Day 42 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score [Baseline up to Day 42]

    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 90-second time limit. Higher scores indicate better processing speed. Positive change from baseline indicates better processing speed.

Secondary Outcome Measures

  1. Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) and TEAEs by Severity [Up to Day 70]

  2. Number of Participants who Withdraw Due to Adverse Events (AEs) [Up to Day 70]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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; Meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria).

  2. For participants meeting Level 1 PD-MCI criteria, have a Montreal Cognitive Assessment (MoCA) score of 20 to 25 (inclusive) at Screening.

  3. For participants meeting Level 2 PD-MCI criteria (within the past year), have a MoCA score of 18 to 25 (inclusive) at Screening.

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

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

Exclusion Criteria:
  1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia associated with PD (probable or possible), 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sage Investigational Site Hialeah Florida United States 33012
2 Sage Investigational Site Miami Florida United States 33032
3 Sage Investigational Site Port Orange Florida United States 32127
4 Sage Investigational Site Winter Park Florida United States 32789
5 Sage Investigational Site Decatur Georgia United States 30030
6 Sage Investigational Site Virginia Beach Virginia United States 23502

Sponsors and Collaborators

  • Sage Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sage Therapeutics
ClinicalTrials.gov Identifier:
NCT05318937
Other Study ID Numbers:
  • 718-CNP-202
First Posted:
Apr 8, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022