Skip to main content
Delfa

← Trials/Trial dossier/NCT00866060

DOMINO-AD

UnknownPhase 4

Donepezil and Memantine in Moderate to Severe Alzheimer's Disease

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

Org study ID2006/123
SecondaryEudract 2007-001172-36
SecondaryISRCTN49545035
NCT IDNCT00866060

Timeline

Milestones

Study start2008-02 (month precision)
Study first posted2009-03-20estimated
Last update posted2009-03-20estimated
Primary completion2012-02estimated (month precision)
Study completion2013-06estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

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

Caregiver / quality of life
2
Global cognition
1
Function / daily living
1
Behavior / neuropsychiatric
1
Disease progression
1
Other (unclassified)
1

Global cognition

1 endpoint
Primary/protocol endpoint

Cognitive Function measured with the Standardised MMSE (SMMSE).

Time frame:4 years

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint
Primary/protocol endpoint

Activities of Daily Living measured with the Bristol Activities of Daily Living scale (BADLS).

Time frame:4 years

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Non-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 endpoint
Secondary/protocol endpoint

Institutionalisation 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 endpoints
Secondary/protocol endpoint

Health-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

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint/low confidence

Care-giver burden measured with the General Health Questionnaire.

Time frame:4 years

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.