Clinical trial NCT04602624: A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (AD)
Official title: An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Cognitive Dysfunction
Mild Dementia
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive and neuropsychiatric symptoms in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD).


Eligibility criteria: Inclusion Criteria:

1. Participant meets the following criteria for MCI or mild dementia due to AD at Screening: has a memory complaint, has clinical dementia rating (CDR) score of 0.5 to 1.0 (inclusive) with a memory box score ≥0.5, has essentially preserved activities of daily living
2. Participant has a score of 15 to 24 (inclusive) on the Montreal Cognitive Assessment at Screening
3. Participant has normal premorbid intelligence quotient (IQ) at Screening
4. Participant has a study partner who is reliable, competent, at least 18 years of age, willing to be available to the study center by phone, support study-specific activities, and accompany the participant to study visits as needed

Exclusion Criteria:

1. Participant has any medical or neurological condition (other than AD) that might be contributing to the participant's cognitive impairment or history of cognitive decline
2. Participant has 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
3. Participant has a history, presence, and/or current evidence of a clinically-significant intracranial abnormality (eg, stroke, hemorrhage, space-occupying lesion) that could account for the observed cognitive impairment (excluding abnormalities consistent with underlying AD pathology)
4. Participant has a history of possible or probable cerebral amyloid angiopathy, according to the Boston Criteria
5. Participant has a history of seizures or epilepsy, with the exception of a single episode of febrile seizures in childhood
6. Participant has current or recent suicidality

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to last follow up visit (up to 28 days)
Secondary outcomes:
measure: Percentage of Participants With at Least One Potentially Clinically Significant (PCS) Change in Vital Signs Measurements
timeFrame: From first dose of study drug up to last follow-up visit (up to 28 days)
measure: Percentage of Participants With at Least One Potentially Clinically Significant Change in Laboratory Assessments
timeFrame: From first dose of study drug up to last follow-up visit (up to 28 days)
measure: Percentage of Participants With at Least One Potentially Clinically Significant Change in Electrocardiogram (ECG) Measurements
timeFrame: From first dose of study drug up to last follow-up visit (up to 28 days)
measure: Percentage of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Sage Investigational Site
state: Arizona
city: Redlands
country: United States
facility: Sage Investigational Site
state: California
city: Miami
country: United States
facility: Sage Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Sage Investigational Site
state: Florida
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Gaithersburg
country: United States
facility: Sage Investigational Site
state: Maryland
city: Farmington Hills
country: United States
facility: Sage Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Sage Investigational Site
state: Nebraska
city: North Canton
country: United States
facility: Sage Investigational Site
state: Ohio
Study officials:
References: