A Study to Evaluate the Effects of SAGE-718 in Participan... | NCT05318937

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received SAGE-718-matching placebo, oral capsules, once daily (QD), in the morning for 42 days.	Drug: SAGE-718-matching placebo
SAGE-718	Experimental	Participants received SAGE-718, 1.2 milligrams (mg), oral capsules, QD in the morning for 42 days.	Drug: SAGE-718

Name	Type	Description	Arm Group Labels	Other Names
SAGE-718-matching placebo	Drug	Oral capsules	Placebo
SAGE-718

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score	The WAIS-IV coding test is a valid and sensitive measure of cognitive dysfunction that correlates with real-world functional outcomes (e.g., the ability to accomplish everyday tasks) and recovery from functional disability used to assess processing speed. The participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The total score ranges from 0 to 135 and is based on the total number of codes correctly completed over a 120-second time limit. Higher scores indicate better processing speed. Positive change from baseline indicates better processing speed. Least Squares (LS) Means were calculated using a mixed-effects model for repeated measures (MMRM) approach.	Baseline, Day 42

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered 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 (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE on or after 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
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.
Meet criteria for modified 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.
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:

Have a diagnosis of dementia of any etiology, including but not limited to: Dementia with Lewy bodies, Alzheimer's dementia, and vascular dementia.
Have any parkinsonism other than PD, including secondary parkinsonism or atypical parkinsonism.
In the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with PD that will interfere with completing study procedures.
Have an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study.
Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator.
Have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury.
Have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion).

Facility	Status	City	State	ZIP	Country	Contacts
Sage Investigational Site		Sun City	Arizona	85351	United States
Sage Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received SAGE-718-matching placebo, oral capsules, once daily (QD), in the morning for 42 days.
FG001	SAGE-718	Participants received SAGE-718, 1.2 milligrams (mg), oral capsules, QD in the morning for 42 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 21, 2022	Jan 15, 2025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0002.0± 1.44 OG0012.0± 1.48

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM		0.9934	The p-value was obtained using a MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.	Difference in LS Means	-0.0	Standard Error of the Mean	2.07	2-Sided	95	-4.13	4.09			Difference was calculated as SAGE-718 - placebo.		Superiority

Secondary

Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered 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 (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE on or after 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.

The safety set included all participants who were administered at least one dose of the IP.

Posted

Count of Participants

Participants

Up to Day 70

ID	Title	Description
OG000	Placebo	Participants received SAGE-718-matching placebo, oral capsules, QD in the morning for 42 days.
OG001	SAGE-718	Participants received SAGE-718, 1.2 mg, oral capsules, QD in the morning for 42 days.

Units	Counts

Secondary

Number of Participants With at Least One TEAE by Severity

A TEAE is defined as any AE on or after 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. Severity was assessed as:

Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms
Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed
Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized.

Participant with multiple instances of events is counted only once using maximum intensity.

The safety set included all participants who were administered at least one dose of the IP.

Posted

Count of Participants

Participants

Up to Day 70

ID	Title	Description
OG000	Placebo	Participants received SAGE-718-matching placebo, oral capsules, QD in the morning for 42 days.
OG001	SAGE-718	Participants received SAGE-718, 1.2 mg, oral capsules, QD in the morning for 42 days.

Secondary

Number of Participants Who Withdrew From Study Due to TEAEs

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered 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 (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE on or after 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.

The safety set included all participants who were administered at least one dose of the IP.

Posted

Count of Participants

Participants

Up to Day 70

ID	Title	Description
OG000	Placebo	Participants received SAGE-718-matching placebo, oral capsules, QD in the morning for 42 days.
OG001	SAGE-718	Participants received SAGE-718, 1.2 mg, oral capsules, QD in the morning for 42 days.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected43 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected43 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected43 at risk
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected43 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected43 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected43 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected43 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected43 at risk

ID	Term
D010300	Parkinson Disease
D060825	Cognitive Dysfunction

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Title	Description
BG000	Placebo	Participants received SAGE-718-matching placebo, oral capsules, QD in the morning for 42 days.
BG001	SAGE-718	Participants received SAGE-718, 1.2 mg, oral capsules, QD in the morning for 42 days.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received SAGE-718-matching placebo, oral capsules, QD in the morning for 42 days.	1	43	2	43	4	43
EG001	SAGE-718	Participants received SAGE-718, 1.2 mg, oral capsules, QD in the morning for 42 days.	0	43	3	43	5	43

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Urinary tract infection	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment		EG0003 affected43 at risk EG0013 affected43 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment		EG0001 affected43 at risk EG0013 affected43 at risk