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

NCT04476017 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 718-CNP-201
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive impairment (PD-MCI).

Conditions

Parkinson Disease; Cognitive Dysfunction

Keywords

Parkinson's Disease; Cognitive Dysfunction; SAGE-718

Outcome Measures

Primary Outcomes (2)

• Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

  An adverse event (AE) was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal.

  From first dose of study drug up to 28 days

• Part B: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

  An AE was any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. TEAEs were defined as an AE with an onset date on or after the date of the first dose of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Percentages are rounded off to the nearest single decimal.

  From first dose of study drug up to 42 days

Secondary Outcomes (4)

• Part A and B: Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements

  From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

• Part A and B: Percentage of Participants With Clinically Significant Changes in Laboratory Assessments

  From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

• Part A and B: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements

  From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

• Part A and B: Percentage of Participants With a Response of 'Yes' to Any Suicidal Ideation or Suicidal Behaviors Item Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

  From first dose of study drug up to 28 days for Part A, and up to 42 days for Part B

Study Arms (2)

Part A: SAGE-718 3 mg

EXPERIMENTAL

Participants received SAGE-718 3 milligrams (mg) tablets, once daily with food in the morning for 14 days.

Drug: SAGE-718

Part B: SAGE-718 3 mg

EXPERIMENTAL

Participants received SAGE-718 3 mg tablets, once daily with food in the morning for 28 days.

Drug: SAGE-718

Interventions

SAGE-718 DRUG

Oral tablets.

Part A: SAGE-718 3 mg; Part B: SAGE-718 3 mg

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening.
• Meet criteria for Hoehn \& Yahr Stage I to III (mild to moderate motor severity) at Screening.
• Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of the investigator.

You may not qualify if:

• 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.
• Have any indication of parkinsonism other than idiopathic PD.
• In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD.
• 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.
• 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.
• Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (4)

Sage Investigational Site

Long Beach, California, 90806, United States

Location

Sage Investigational Site

Port Charlotte, Florida, 33980, United States

Location

Sage Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Sage Investigational Site

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Monitor
• Organization: Sage Therapeutics

info@sagerx.com

(617) 299-8380

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study had two parts: Part A and Part B with unique participants for each study part. Part B was started after Part A was completed.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 17, 2020
• Study Start: July 31, 2020
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: September 15, 2025
• Results First Posted: June 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)