Condition category
Nervous System Diseases
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
28/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Jane Douglas

ORCID ID

Contact details

The Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4159

Study information

Scientific title

Acronym

DONIPAD

Study hypothesis

This is a single-centre, double-blind, placebo-controlled, cross-over study to assess the efficacy of donepezil in patients with the posterior variant of Alzheimer's disease.

This trial aims to identify the objective neuropsychological benefit of donepezil in patients with the posterior variant of Alzheimer's disease. There have been no previous studies to assess the effectiveness of donepezil in the posterior variant of Alzheimer's disease. Clinical observation suggests that this group may respond particularly well to cholinesterase inhibitors.

Ethics approval

MREC approved, ref: 03N025

Study design

Single-centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Dementia

Intervention

Patients will have baseline mini-mental state examination and neuropsychological tests for specific occipito-parietal functions. Patients will be randomised to receive donepezil 5 mg or placebo once daily for 6 weeks.

They will then be reassessed before increasing the dose to 10 mg donepezil in the treatment arm for a further 6 weeks, or continuing placebo in the other arm. They will be assessed at the end of this period before discontinuing the study drug for a 2-week washout period.

Follow-up length: 6 months
Study entry: single randomisation only

Intervention type

Drug

Phase

Not Applicable

Drug names

Donepezil

Primary outcome measures

Mini Mental State Examination, measured at 0 weeks and 6 weeks

Secondary outcome measures

1. Digit span
2. Letter cancellation speed test
3. Simple calculation test
4. VOSP dot counting test
5. VOSP number location test

Overall trial start date

27/06/2003

Overall trial end date

30/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical diagnosis of posterior variant of Alzheimer's disease
2. Memory test score above the 5th percentile on neuropsychological assessment
3. Absence of other causes of cognitive impairment based on dementia screen investigations available
4. Male and female, lower age limit of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 20; UK sample size: 20

Participant exclusion criteria

1. Significant neurological or psychiatric disease other than Alzheimer's disease
2. Significant systemic disease
3. Medications with the potential to affect cognition unless maintained on a stable dose for at least 3 months

Recruitment start date

27/06/2003

Recruitment end date

30/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Institute of Neurology
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Industry

Funder name

Eisai Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes