Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0577150953
Study information
Scientific title
A randomised placebo-controlled trial of polyunsaturated omega-3 fatty acid (PFA), in the treatment of dementia: a pilot study
Acronym
Study hypothesis
A pilot study to evaluate the conjunctive, functional and behavioural effects of dietary supplementation of omega-3 PFA in elderly patients with dementia.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Dementia
Intervention
Randomised double-blind placebo-controlled trial
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Improvements in mood, cognition, quality of life on the functioning measures MMSE, QOL-AD, GHQ-12, CIBIC and neuropsychological battery subjects.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2004
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
50 outpatient attendees at a Memory Clinic with a diagnosis of dementia (MMSE score 17-24)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
50
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/09/2004
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North East London Mental Health Trust
Brentwood
CM14 5HQ
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
Funders
Funder type
Hospital/treatment centre
Funder name
North East London Mental Health NHS Trust (NELMHT), Research & Development Department (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