CompletedPhase 4Results posted

Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer

Interventional, Randomised, Double-blind, Study to Evaluate the Safety and Tolerability of Once Daily Versus Twice Daily Memantine Treatment in Patients With Dementia of Alzheimer's Type and MMSE Range 5 - 18

Lead sponsor

H. Lundbeck A/S

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 5-18•Study partner/caregiver required

Primary endpoint

•Adverse Events

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 ID14603A

NCT IDNCT02553928

Timeline

Milestones

Study first posted2015-09-18estimated

Study start2015-10 (month precision)

Primary completion2016-07actual (month precision)

Study completion2016-07actual (month precision)

Last update posted2019-03-14actual

Results first posted2019-03-14actual

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.

•The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.

•The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit

•The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening

Exclusion criteria

•The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.

•The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.

•The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD

•The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor

Other protocol defined inclusion and exclusion criteria may apply

Endpoints (4)

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

Behavior / neuropsychiatric

Safety / tolerability / PK

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

ADCS - CGIC Score at Week 12

Time frame:ADCS - CGIC score at Week 12

descriptive

Secondary/registry result

ADCS - CGIC Score at Week 12

Time frame:ADCS - CGIC score at Week 12

descriptive

Posted result

Group	Value (mean), units on a scale	Standard error
Memantine (Once Daily)n=29 Participants	3.92	0.14
Memantine (Twice Daily)n=29 Participants	3.60	0.14

Mean Difference (Final Values)0.3295% CI-0.06 - 0.69p0.097ANCOVA

The ADCS-CGIC was analyzed based on an analysis of covariance (ANCOVA) of ADCS-CGIC score at Week 12, with treatment and site as fixed factors, and baseline score as a covariate using observed cases.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Adverse Events

Time frame:baseline to week 16 (end of study)

event count, event

Primary/registry result

Adverse Events

Time frame:baseline to week 16 (end of study)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Memantine (Once Daily)n=30 Participants	15	-
Memantine (Twice Daily)n=32 Participants	16	-

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.