Donepezil and Memantine in moderate to severe Alzheimer's Disease - DOMINO - AD

• Conditions: Moderate to severe alzheimer's disease; MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease

• Registration Number: EUCTR2007-001172-36-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients will be eligible to participate if: they meet NINCDS-ADRDA criteria for probable or possible Alzheimer’s disease.

In addition to be eligible patients will need meet the following criteria:

1) SMMSE = 5 to 13
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 (see consent above)
8) Main carer (informal or professional) consents to their own involvement and the patient’s

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified