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

• ClinicalTrials.gov Identifier: NCT04476017
• Recruitment Status: Completed
• First Posted: July 17, 2020
• Last Update Posted: April 25, 2022
• Sponsor: Sage Therapeutics
• Information provided by (Responsible Party): Sage Therapeutics

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 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
• Actual Primary Completion Date: March 25, 2022
• Actual Study Completion Date: March 25, 2022

Arms and Interventions

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.

Outcome Measures

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).

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Arizona

Sage Investigational Site

Phoenix, Arizona, United States, 85044

United States, California

Sage Investigational Site

Long Beach, California, United States, 90806

United States, Florida

Sage Investigational Site

Boca Raton, Florida, United States, 33486

Sage Investigational Site

Port Charlotte, Florida, United States, 33980

Sage Investigational Site

Saint Petersburg, Florida, United States, 33713

Sage Investigational Site

West Palm Beach, Florida, United States, 33407

United States, Georgia

Sage Investigational Site

Atlanta, Georgia, United States, 30331

United States, Illinois

Sage Investigational Site

Chicago, Illinois, United States, 60612

United States, Maryland

Sage Investigational Site

Gaithersburg, Maryland, United States, 20877

United States, Nebraska

Sage Investigational Site

Omaha, Nebraska, United States, 68130

United States, Pennsylvania

Sage Investigational Site

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Sage Therapeutics

More Information

• Responsible Party: Sage Therapeutics
• ClinicalTrials.gov Identifier: NCT04476017
• Other Study ID Numbers: 718-CNP-201
• First Posted: July 17, 2020
• Last Update Posted: April 25, 2022
• Last Verified: April 2022

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.

• 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:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Synucleinopathies