ROMEO-AD

UnknownPhase 4

Effect of Memantine Oral Pump on Language in Patients With Probable Alzheimer's Disease

A Multicenter, Randomized, Open-label, Prospective Study to Estimate the add-on Effects of Memantine as Ebixa Oral Pump on Language in Moderate to Severe Alzheimer's Disease Patients Already Receiving Donepezil.

Lead sponsor

Konkuk University Medical Center

Assets

Donepezil / Memantine

Listed sites

Recruiting sites

Enrollment

188

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤20•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•AQ-WAB

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

NCT IDNCT01849042

Org study IDROMEO-AD 14394A

Timeline

Milestones

Study start2013-01 (month precision)

Study first posted2013-05-08estimated

Primary completion2014-08estimated (month precision)

Last update posted2014-08-13estimated

Study completion2015-08estimated (month precision)

Assets

Drug assets

Donepezil Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria

•MMSE score equal to or less than 20

•Brain CT or MRI scan performed within the past 12 months

•living or having regular visit at least three times a week from caregiver

•able to visit outpatient clinic and to perform cognitive function test

•already taking stable dose of donepezil for 3 months prior to screening

•subject and caregiver who signed informed consent

Exclusion criteria

•involved in another clinical trial within 4 weeks prior to screening

•severe or unstable disease: acute or severe asthma, unstable or severe cardiovascular disease, acute peptic ulcer,chronic renal failure

•bradycardia (pulse rate less than 50bpm), sick sinus syndrome

•any laboratory finding including cognitive impairments(vitamine B12 or folic acid, syphilis, thyroid disease)

•severe auditory or visual disturbance

•other degenerative disease or psychosis

•taken any drug used for the treatment of Alzheimer's disease or dementia

Endpoints (3)

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

Executive function / language

Other (unclassified)

Global cognition

1 endpoint

Other/protocol endpoint

SIB-short form

Time frame:six months

descriptive

Executive function / language

1 endpoint

Primary/protocol endpoint

AQ-WAB(Western aphasia battery)

Time frame:Six months

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

ROSA (Relevant Outcome Scale for Alzheimer's Disease)

Time frame:six months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.