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Trial record 2 of 2 for:    SAGE-718 | Parkinson Disease | United States
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A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT05318937
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : May 3, 2023
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 effect of SAGE-718 on cognitive performance in participants with Parkinson's disease mild cognitive impairment (PD-MCI).

Condition or disease Intervention/treatment Phase
Parkinson Disease Cognitive Dysfunction Drug: SAGE-718 Drug: SAGE-718-matching placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 6, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

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 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
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Primary Outcome Measures :
  1. Change from Baseline to Day 42 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score [ Time Frame: 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 120-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 [ Time Frame: Up to Day 70 ]
  2. Number of Participants who Withdraw Due to Adverse Events (AEs) [ Time Frame: Up to Day 70 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
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): NCT05318937


Contacts
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Contact: Adnan Mahmood, MD 1-617-982-9295 Adnan.Mahmood@sagerx.com

Locations
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United States, Arizona
Sage Investigational Site Recruiting
Sun City, Arizona, United States, 85351
Contact       clinicaltrialsinquiry@sagerx.com   
United States, California
Sage Investigational Site Recruiting
Long Beach, California, United States, 90806
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Reseda, California, United States, 91335
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Colorado
Sage Investigational Site Recruiting
Englewood, Colorado, United States, 80113
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Connecticut
Sage Investigational Site Recruiting
Vernon, Connecticut, United States, 06066
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Florida
Sage Investigational Site Recruiting
Boca Raton, Florida, United States, 33486
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Hialeah, Florida, United States, 33012
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33032
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Orlando, Florida, United States, 32789
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Port Orange, Florida, United States, 32127
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Tampa, Florida, United States, 33613
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Georgia
Sage Investigational Site Recruiting
Decatur, Georgia, United States, 30030
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Illinois
Sage Investigational Site Recruiting
Chicago, Illinois, United States, 60611
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Kansas
Sage Investigational Site Recruiting
Kansas City, Kansas, United States, 66160
Contact       clinicaltrialsinquiry@sagerx.com   
United States, New York
Sage Investigational Site Recruiting
Albany, New York, United States, 12208
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
New York, New York, United States, 10019
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Woodmere, New York, United States, 11598
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Ohio
Sage Investigational Site Recruiting
Cincinnati, Ohio, United States, 45221
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Columbus, Ohio, United States, 43221
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Tennessee
Sage Investigational Site Recruiting
Nashville, Tennessee, United States, 37232
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Vermont
Sage Investigational Site Recruiting
Burlington, Vermont, United States, 05401
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Virginia
Sage Investigational Site Recruiting
Virginia Beach, Virginia, United States, 23502
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT05318937    
Other Study ID Numbers: 718-CNP-202
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
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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Parkinson Disease
Cognition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognitive Dysfunction
Synucleinopathies