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

• Sponsor: Sage Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04476017
• Collaborator: (none)
• Enrollment: 18
• Locations: 11
• Arms: 2
• Actual Duration (Months): 18.4
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0.1

Study Details

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
• 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: Sep 11, 2020
• Actual Primary Completion Date: Mar 25, 2022
• Actual Study Completion Date: Mar 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) [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 [Part A: up to Day 28; Part B: up to Day 42]

2. Percentage of Participants With Clinically Significant Changes in Laboratory Assessments [Part A: up to Day 28; Part B: up to Day 42]

3. Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements [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) [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

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 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

	Site	City	State	Country	Postal Code
1	Sage Investigational Site	Phoenix	Arizona	United States	85044
2	Sage Investigational Site	Long Beach	California	United States	90806
3	Sage Investigational Site	Boca Raton	Florida	United States	33486
4	Sage Investigational Site	Port Charlotte	Florida	United States	33980
5	Sage Investigational Site	Saint Petersburg	Florida	United States	33713
6	Sage Investigational Site	West Palm Beach	Florida	United States	33407
7	Sage Investigational Site	Atlanta	Georgia	United States	30331
8	Sage Investigational Site	Chicago	Illinois	United States	60612
9	Sage Investigational Site	Gaithersburg	Maryland	United States	20877
10	Sage Investigational Site	Omaha	Nebraska	United States	68130
11	Sage Investigational Site	Philadelphia	Pennsylvania	United States	19107

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: NCT04476017
• Other Study ID Numbers: 718-CNP-201
• First Posted: Jul 17, 2020
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 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
• 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; Cognitive Dysfunction

Study Results

No Results Posted as of Apr 25, 2022