CompletedPhase 2Results posted

SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study

A Phase 2a Multicenter, Randomized, Double-Blind, Parallel Group, 26-Week, Placebo-Controlled Study of SUVN-502 in Subjects With Moderate Alzheimer's Disease Currently Treated With Donepezil Hydrochloride and Memantine Hydrochloride

Lead sponsor

Suven Life Sciences Limited

Assets

Donepezil / Masupirdine / Memantine

Listed sites

Recruiting sites

Enrollment

564

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-20•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCTP2S1502HT6

NCT IDNCT02580305

Timeline

Milestones

Study start2015-09 (month precision)

Study first posted2015-10-20estimated

Primary completion2019-11-05actual

Study completion2019-11-07actual

Last update posted2023-06-09actual

Results first posted2023-06-09actual

Assets

Drug assets

Donepezil Masupirdine Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 1 year prior to the screening visit.

•Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline visits.

•Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies.

•Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for at least 3 months prior to the screening visit

•Availability of an eligible and reliable caregiver

•Must be living in the community or an assisted living facility.

•Must be ambulatory or ambulatory aided (use of cane or walker).

•Is not pregnant or planning to become pregnant during the study.

•Subject (or subject's legally acceptable representative) and caregiver must sign an Informed Consent to participate in the study

Exclusion criteria

•Has a diagnosis of dementia due to other than Alzheimer's Disease

•Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of donepezil HCl other than 10 mg

•Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd.

•Has uncontrolled cardiac disease or hypertension.

•Has clinically significant renal or hepatic impairment.

•Has cancer or a malignant tumor, untreated thyroid disorder or has a history of seizure disorder

•Is treated or likely to require treatment during the study, with any medications prohibited by the study protocol.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Global cognition

6 endpoints

Primary/protocol endpoint

Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)

Time frame:Baseline to Week 26

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)

Time frame:Baseline to Week 26

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
SUVN-502 Low Dose (50 mg)n=184 Participants	2.0	0.5
SUVN-502 High Dose (100 mg)n=176 Participants	2.5	0.5
Placebon=183 Participants	2.6	0.5

p0.41Mixed Models Analysis

p0.90Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Time frame:Baseline to Week 26

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)

Time frame:Baseline to Week 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Time frame:Baseline to Week 26

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
SUVN-502 Low Dose (50 mg)n=184 Participants	1.3	0.2
SUVN-502 High Dose (100 mg)n=176 Participants	1.0	0.2
Placebon=183 Participants	1.2	0.2

p0.46Mixed Models Analysis

p0.48Mixed Models Analysis

Secondary/registry result

Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)

Time frame:Baseline to Week 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
SUVN-502 Low Dose (50 mg)n=184 Participants	-1.1	0.3
SUVN-502 High Dose (100 mg)n=176 Participants	-1.1	0.3
Placebon=183 Participants	-1.0	0.3

p0.79Mixed Models Analysis

p0.92Mixed Models Analysis

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline to Week 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)

Time frame:Baseline to Week 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
SUVN-502 Low Dose (50 mg)n=184 Participants	-4.6	0.6
SUVN-502 High Dose (100 mg)n=176 Participants	-3.4	0.6
Placebon=183 Participants	-4.4	0.6

p0.83Mixed Models Analysis

p0.24Mixed Models Analysis

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)

Time frame:Baseline to Week 26

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)

Time frame:Baseline to Week 26

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
SUVN-502 Low Dose (50 mg)n=184 Participants	0.5	0.8
SUVN-502 High Dose (100 mg)n=176 Participants	0.4	0.9
Placebon=183 Participants	2.1	0.8

p0.17Mixed Models Analysis

p0.14Mixed Models Analysis

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.