A randomised, double blind, placebo-controlled clinical trial to compare the progression of cognitive impairment in dementia patients continuing to take, or discontinued from, treatment with neuroleptics
| ISRCTN | ISRCTN33368770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33368770 |
| Protocol serial number | N0504126576 |
| Sponsor | Department of Health |
| Funder | Northumbria Healthcare NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 11/11/2008
- 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
Prof CG Ballard
Scientific
Scientific
Institute for Ageing and Health
Newcastle General Hospital
West Road
Newcastle upon Tyne
NE4 6BE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, placebo-controlled clinical trial |
| Secondary study design | International |
| Scientific title | |
| Study objectives | The hypothesis that the study is designed to test is that in a randomised study, treatment with neuroleptic agents will be associated with an accelerated rate of cognitive decline in dementia patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Dementia |
| Intervention | Dementia patients continuing to take, or discontinued from, treatment with neuroleptics. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Neuroleptics |
| Primary outcome measure(s) |
The primary outcome will be cognitive change on the Severe Impairment Battery. |
| Key secondary outcome measure(s) |
The ADL measures, CAMCOG (including MMSE), FAST and other cognitive assessments will be evaluated as secondary outcomes. |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 220 |
| Key inclusion criteria | 220 patients who will be living in nursing homes, at home with a carer, or in sheltered accommodation who fulfil the NINCDS/ADRDA for probable or possible Alzheimer's Disease and who have been taking neuroleptic medication for a minimum of three months |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute for Ageing and Health
Newcastle upon Tyne
NE4 6BE
United Kingdom
NE4 6BE
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 | 01/04/2008 | Yes | No |
