Efficacy of donepezil in the posterior variant of Alzheimer's disease (posterior cortical atrophy) study

ISRCTN	ISRCTN22636071
DOI	https://doi.org/10.1186/ISRCTN22636071
Secondary identifying numbers	4159

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 17/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Jane Douglas
Scientific

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

Study information

Study design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Efficacy of DONepezil in the Posterior variant of Alzheimer's Disease (posterior cortical atrophy) study
Study acronym	DONIPAD
Study objectives	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(s)	MREC approved, ref: 03N025
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Donepezil
Primary outcome measure	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 study start date	27/06/2003
Completion date	30/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 20; UK sample size: 20
Key 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
Key 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
Date of first enrolment	27/06/2003
Date of final enrolment	30/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Institute of Neurology

London
WC1N 3BG
United Kingdom

Sponsor information

University College London (UCL) (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Industry

Eisai Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2018		Yes	No

Editorial Notes

17/01/2019: Publication reference added.
18/04/2017: No publications found, verifying study status with principal investigator.