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A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia that is Unresponsive to a Psychological Intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62185868
Enrollment
285
Registered
2000-09-21
Start date
2003-11-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurosciences, psychiatry Nervous System Diseases Dementia

Interventions

Randomised to receive: 1. Risperidone 0.5-1.0 mg 2. Donepezil 5-10mg 3. Placebo For 12 weeks.

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Probable or possible Alzheimer's disease (AD) 2. Clinically significant agitation 3. Age >39 years 4. Resident in care facility or community resident with carer 5. Not receiving treatment with neuroleptics or chlornesterase inhibitors 6. Carer with capacity to consent.

Exclusion criteria

Exclusion criteria: 1. Known sensitivity to donepezil or resperidone 2. Severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations 3. Current evidence of delirium 4. Patient meets criteria for Probable Dementia with Lewy Bodies (McKeith et al, 1996) 5. Low probability of treatment compliance

Design outcomes

Primary

MeasureTime frame
A reduction in score on the Cohen Mansfield Agitation Inventory.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026