Donepezil and memantine in moderate to severe Alzheimer's disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 800

Inclusion Criteria

Participants will be patients who meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable or possible AD and in addition will meet all of the following criteria:
1. Continuously prescribed donepezil for at least three months
2. No change in dosage of donepezil in previous six weeks
3. No changes in prescription of any psychotropic (antipsychotic, antidepressant, benzodiazepine) medication in previous four weeks
4. Prescribing clinician considers (based on National Institute of Clinical Excellence [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 and Standardised Mini Mental State Exam (SMMSE) = 5 to 13 (13 chosen as NICE threshold of 10 plus 1 SD on SMMSE score)
5. Patient is community resident and has family or professional carer or is visited on at least a daily basis by carer
6. Patient agrees to participate where possible
7. Main carer (informal or institutional) consents to their own involvement

Exclusion Criteria

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
4. Patient is involved in another clinical trial
5. Patient has absolute contraindication to either donepezil or memantine
6. Clinician considers patient would not be compliant with medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cognitive function measured by the Standardised Mini Mental State Exam (SMMSE)<br>2. Activities of daily living measured using the Bristol Activities of Daily Living Scale (BADLS)<br><br>All measures will be taken at zero, six, 18, 30 and 52 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Non-cognitive dementia symptoms measured using the neuropsychiatric inventory <br>2. Health related quality of life measured by Euro Quality of Life (EQ-5D) questionnaire and Demential Quality of Life (DEMQOL)-proxy<br>3. Care giver burden measured by the 12-item General Health Questionnaire (GHQ-12)<br>4. Cost effectiveness measured using the client service receipt inventory in conjunction with SMMSE and BADLS results<br><br>All measures will be taken at zero, six, 18, 30 and 52 weeks.

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