Efficacy of donepezil in the posterior variant of Alzheimer's disease (posterior cortical atrophy) study
| ISRCTN | ISRCTN22636071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22636071 |
| Protocol serial number | 4159 |
| Sponsor | University College London (UCL) (UK) |
| Funder | Eisai Ltd (UK) |
- 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
Scientific
The Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Donepezil |
| Primary outcome measure(s) |
Mini Mental State Examination, measured at 0 weeks and 6 weeks |
| Key secondary outcome measure(s) |
1. Digit span |
| Completion date | 30/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The Institute of Neurology
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/01/2019: Publication reference added.
18/04/2017: No publications found, verifying study status with principal investigator.
