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A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)

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ClinicalTrials.gov Identifier: NCT04476017
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The primary purpose of this two-part study is to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with PD-MCI.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A: SAGE-718
Participants will receive SAGE-718 tablets, once daily with food in the morning for 14 days.
Drug: SAGE-718
SAGE-718 oral tablets.

Experimental: Part B: SAGE-718
Participants will receive SAGE-718 tablets, once daily with food in the morning for 28 days.
Drug: SAGE-718
SAGE-718 oral tablets.




Primary Outcome Measures :
  1. Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Part A: up to Day 28; Part B: up to Day 42 ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that occurs after the first administration of a study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements [ Time Frame: Part A: up to Day 28; Part B: up to Day 42 ]
  2. Percentage of Participants With Clinically Significant Changes in Laboratory Assessments [ Time Frame: Part A: up to Day 28; Part B: up to Day 42 ]
  3. Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements [ Time Frame: Part A: up to Day 28; Part B: up to Day 42 ]
  4. Percentage of Participants With Change in Baseline for Responses on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Part A: Baseline and Days 1, 7, 14, and 28; Part B: Baseline and Days 1, 7, 14, 21, 28, 35, and 42 ]
    The C-SSRS scale consists of a baseline evaluation (at screening) that assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).



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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 PD according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet MDS Task Force Criteria for MCI in PD.
  2. Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening.
  3. Meet criteria for 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.

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 indication of parkinsonism other than idiopathic PD.
  3. In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD.
  4. Have an ongoing central nervous system condition other than idiopathic PD, including active neurologic and/or nonremitted psychiatric disorders, in the opinion of the investigator.
  5. Have a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury.
  6. Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.

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): NCT04476017


Contacts
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Contact: Aaron Koenig 617-949-5576 Aaron.koenig@sagerx.com

Locations
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United States, Arizona
Sage Investigational Site Recruiting
Phoenix, Arizona, United States, 85044
Contact       clinicaltrialsinquiry@sagerx.com   
United States, California
Sage Investigational Site Recruiting
Long Beach, California, United States, 90806
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
Port Charlotte, Florida, United States, 33980
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Saint Petersburg, Florida, United States, 33713
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
West Palm Beach, Florida, United States, 33407
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Georgia
Sage Investigational Site Recruiting
Atlanta, Georgia, United States, 30331
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Maryland
Sage Investigational Site Recruiting
Gaithersburg, Maryland, United States, 20877
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Nebraska
Sage Investigational Site Recruiting
Omaha, Nebraska, United States, 68130
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT04476017    
Other Study ID Numbers: 718-CNP-201
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sage Therapeutics:
Parkinson's Disease
Cognitive Dysfunction
SAGE-718
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders