Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in Mild Cognitive Impairment (MCI) Patients and the Influence of the APOE-epsilon4 Allele

This study is currently recruiting participants.

Verified by Wageningen University, October 2008

Sponsors and Collaborators:	Wageningen University Radboud University
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00746005

Purpose

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.

Condition	Intervention
Mild Cognitive Impairment	Dietary Supplement: fish oil Dietary Supplement: placebo, sunflower oil

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele

Further study details as provided by Wageningen University:

Primary Outcome Measures:

cognitive performance [ Time Frame: baseline and after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 3 g EPA-DHA	Dietary Supplement: fish oil 3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
2: Placebo Comparator Placebo: sunflower oil	Dietary Supplement: placebo, sunflower oil 3 g of sunflower oil

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746005

Contacts

Contact: Ondine van de Rest, MSc	0031 31748567	Ondine.vandeRest@wur.nl
Contact: Ondine van de Rest, MSc	0031 317485767	Ondine.vandeRest@wur.nl

Locations

Netherlands, Gelderland
Radboud University Medical Center	Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GC
Contact: William van Aalst, MD 0031 024 3616776 ext 2617 W.vanAalst@ger.umcn.nl
Principal Investigator: Marcel OldeRikkert, MD, PhD
Sub-Investigator: Jurgen Claassen, MD
Sub-Investigator: Roy Kessels, PhD
Ziekenhuis Gelderse Vallei	Not yet recruiting
Ede, Gelderland, Netherlands, 6710 HN
Sub-Investigator: A. Janse, Dr

Sponsors and Collaborators

Wageningen University

Radboud University

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Wageningen University ( Lisette de Groot )
Study ID Numbers:	2008/112
Study First Received:	August 30, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00746005
Health Authority:	Netherlands: Independent Ethics Committee

Keywords provided by Wageningen University:

mild cognitive impairment

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Cognition Disorders
Delirium

ClinicalTrials.gov processed this record on January 14, 2009