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DOMINO-AD
UnknownPhase 4Donepezil and Memantine in Moderate to Severe Alzheimer's Disease
Lead sponsor
Assets
Donepezil / Memantine
Listed sites
1
Recruiting sites
1
Enrollment
800
estimated
Study population
Alzheimer’s disease
Key I/E criterion
•Alzheimer's disease
Primary endpoints
•Mini-Mental State Examination (MMSE)•Activities of Daily Living measured
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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Participants will be patients who meet NINCDS-ADRDA criteria for probable or possible Alzheimer's disease (McKhann et al, 1984). In addition they will meet all of the following criteria:
1. SMMSE = 5 to 13 (13 chosen as NICE threshold of 10 plus 1 SD on SMMSE score)
2. Continuously prescribed donepezil for at least 3 months
3. Maintained on 10mg donepezil in previous 6 weeks.
4. No changes in prescription of any psychotropic (antipsychotic, antidepressant, benzodiazepine) medication in previous 6 weeks.
5. Prescribing clinician considers (based on NICE guidance, discussions with patient and carer and clinical judgement) that change of drug treatment (i.e. stop donepezil or introduce memantine) may be appropriate.
6. Patient is community resident and has family or professional carer or is visited on at least a daily basis by carer.
7. Patient agrees to participate if considered capable (see section 7.5)
8. Main carer (informal or professional) consents to their own involvement and the patient's involvement -
Exclusion criteria
To maximise the generalisability of the study data, exclusions will be kept to a minimum. These will include:
1. Patient has severe, unstable or poorly controlled medical conditions apparent from physical examination or clinical history.
2. Patient is already prescribed memantine.
3. Patient is unable to take trial medications because of contra-indications or previous adverse or allergic reactions.
4. Patient is involved in another clinical trial.
5. Clinician considers patient would not be compliant with trial medication. -
Endpoints (7)
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
1 endpointCognitive Function measured with the Standardised MMSE (SMMSE).
Time frame:4 years
Mini-Mental State Examination (MMSE)
descriptive
Function / daily living
1 endpointActivities of Daily Living measured with the Bristol Activities of Daily Living scale (BADLS).
Time frame:4 years
descriptive
Behavior / neuropsychiatric
1 endpointNon-cognitive dementia symptoms measured with the Neuropsychiatric Inventory (NPI) and the Cohen-Mansfield Agitation Inventory.
Time frame:4 years
Neuropsychiatric Inventory (NPI)
descriptive
Disease progression
1 endpointInstitutionalisation defined as permanent transition from living in an independent household to a care home, NHS continuing care unit or hospital and measured with questions taken from the CSRI and telephone interviews.
Time frame:4 years
descriptive
Caregiver / quality of life
2 endpointsHealth-related quality of life measured with the EQ-5D (Euroqol Group 1990) and the DEMQOL-Proxy (Smith et al 2004) - a carer-rated and disease-specific measure of quality of life in dementia.
Time frame:4 years
descriptive
Cost effectiveness assessed through consideration of the combination of costs generated from the Client Service Receipt Inventory (CSRI) and the assessments of function and quality of life (BADLS, DEMQOL, EQ-5D).
Time frame:4 years
ratio, descriptive
Other (unclassified)
1 endpointCare-giver burden measured with the General Health Questionnaire.
Time frame:4 years
descriptive
Provenance
Sources
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.