Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele

This study has been completed.

Sponsor:

Collaborator:

Radboud University

Information provided by:

Wageningen University

ClinicalTrials.gov Identifier:

NCT00746005

First received: August 30, 2008

Last updated: January 11, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 30, 2008
Last Updated Date	January 11, 2011
Start Date ^ICMJE	October 2008
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2008)	cognitive performance [ Time Frame: baseline and after 4 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00746005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 2, 2008)	blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS [ Time Frame: baseline and after 4 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele
Official Title ^ICMJE	Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele
Brief Summary	To study the short term effects of a pharmacological dose of fish oil on cognitive performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Mild Cognitive Impairment
Intervention ^ICMJE	Dietary Supplement: fish oil 3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg Dietary Supplement: placebo, sunflower oil 3 g of sunflower oil
Study Arm (s)	Experimental: 1 3 g EPA-DHA Intervention: Dietary Supplement: fish oil Placebo Comparator: 2 Placebo: sunflower oil Intervention: Dietary Supplement: placebo, sunflower oil
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	40
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men and women Diagnosed as having amnestic MCI: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic MCI, according to Busse A et al37) Presence of a principal caregiver willing to assist for a successful participation Informed consent signed Exclusion Criteria: Current or recent (<4 weeks) use of fish oil supplements Consumption of fish more than 2 times/week Current use of dementia (Alzheimer) medication Current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil) Serious liver disease Use of more than 4 glasses of alcohol per day Unable to participate as judged by the responsible medical physician Allergy to fish(oil) Swallowing problems Participation in another clinical trial less than 2 months before the start of the trial or at the same time
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT00746005
Other Study ID Numbers ^ICMJE	2008/112
Has Data Monitoring Committee	No
Responsible Party	Lisette de Groot, Wageningen University
Study Sponsor ^ICMJE	Wageningen University
Collaborators ^ICMJE	Radboud University
Investigators ^ICMJE	Not Provided
Information Provided By	Wageningen University
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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