Clinical trial NCT05318937: A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Cognitive Dysfunction
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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 Montreal Cognitive Assessment (MoCA): For participants meeting Level 1 PD-MCI criteria, have a 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).

Primary outcomes:
measure: Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score
timeFrame: Baseline, Day 42
Secondary outcomes:
measure: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to Day 70
measure: Number of Participants With at Least One TEAE by Severity
timeFrame: Up to Day 70
measure: Number of Participants Who Withdrew From Study Due to TEAEs
timeFrame: Up to Day 70
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Sage Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: Sage Investigational Site
state: California
city: Long Beach
country: United States
facility: Sage Investigational Site
state: California
city: Los Angeles
country: United States
facility: Sage Investigational Site
state: California
city: Reseda
country: United States
facility: Sage Investigational Site
state: California
city: Sacramento
country: United States
facility: Sage Investigational Site
state: California
city: Englewood
country: United States
facility: Sage Investigational Site
state: Colorado
city: Vernon
country: United States
facility: Sage Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: Sage Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: Sage Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Sage Investigational Site
state: Florida
city: Tampa
country: United States
facility: Sage Investigational Site
state: Florida
city: Tampa
country: United States
facility: Sage Investigational Site
state: Florida
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Sage Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Sage Investigational Site
state: Kansas
city: Bloomington
country: United States
facility: Sage Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: Sage Investigational Site
state: Nevada
city: Albany
country: United States
facility: Sage Investigational Site
state: New York
city: New York
country: United States
facility: Sage Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Sage Investigational Site
state: New York
city: Williamsville
country: United States
facility: Sage Investigational Site
state: New York
city: Woodmere
country: United States
facility: Sage Investigational Site
state: New York
city: Raleigh
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Sage Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Sage Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Sage Investigational Site
state: Ohio
city: Memphis
country: United States
facility: Sage Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Sage Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Sage Investigational Site
state: Texas
city: Burlington
country: United States
facility: Sage Investigational Site
state: Vermont
city: Virginia Beach
country: United States
facility: Sage Investigational Site
state: Virginia
city: Madison
country: United States
facility: Sage Investigational Site
state: Wisconsin
Study officials:
References: