Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/11/2008
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

Prof CG Ballard

ORCID ID

Contact details

Institute for Ageing and Health
Newcastle General Hospital
West Road
Newcastle upon Tyne
NE4 6BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0504126576

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised, double blind, placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

International

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nervous System Diseases: Dementia

Intervention

Dementia patients continuing to take, or discontinued from, treatment with neuroleptics.

Intervention type

Drug

Phase

Not Specified

Drug names

Neuroleptics

Primary outcome measures

The primary outcome will be cognitive change on the Severe Impairment Battery.

Secondary outcome measures

The ADL measures, CAMCOG (including MMSE), FAST and other cognitive assessments will be evaluated as secondary outcomes.

Overall trial start date

01/06/2002

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

220

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2002

Recruitment end date

31/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Ageing and Health
Newcastle upon Tyne
NE4 6BE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Northumbria Healthcare NHS Trust (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

2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18384230

Publication citations

  1. Results

    Ballard C, Lana MM, Theodoulou M, Douglas S, McShane R, Jacoby R, Kossakowski K, Yu LM, Juszczak E, , A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial)., PLoS Med., 2008, 5, 4, e76, doi: 10.1371/journal.pmed.0050076.

Additional files

Editorial Notes