Preliminary Study of Fish Oil and Dementia - Full Text View

Sponsors and Collaborators:	Taipei City Psychiatric Center, Taiwan Department of Health, Taiwan
Information provided by:	Taipei City Psychiatric Center, Taiwan
ClinicalTrials.gov Identifier:	NCT00628017

Purpose

This preliminary study is aimed to investigate whether it is feasible to conduct a study to use fish oil compared to the placebo(olive oil) in people with cognitive impairment. We will also explore whether fish oil has better efficacy in some clinical aspects in people with cognitive impairment during 24 weeks intervention. The major clinical outcome will be:

general clinical impression
cognitive function

Condition	Intervention
Alzheimer's Disease Mild Cognitive Impairment	Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Fish oil 1,4-Benzenediol Gelatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effects of Omega-3 Fatty Acids Monotherapy in Alzheimer's Disease and Mild Cognitive Impairment: a Preliminary Randomized Double-Blind Placebo-Controlled Study

Further study details as provided by Taipei City Psychiatric Center, Taiwan:

Primary Outcome Measures:

the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mini Mental Status Examination (MMSE) scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
17-item Hamilton Depression Scale (HDRS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	46
Study Start Date:	January 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental omega-3 PUFAs(180mg eicosapentaenoic acid[EPA] + 120mg docosahexaenoic acid[DHA]/capsule), 3 capsules twice daily, total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA	Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA) Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.
2: Placebo Comparator three identical placebo capsules twice daily which contained olive oil esters.	Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA) Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.

Arms

Assigned Interventions

1: Experimental

omega-3 PUFAs(180mg eicosapentaenoic acid[EPA] + 120mg docosahexaenoic acid[DHA]/capsule), 3 capsules twice daily, total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA

Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)

Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.

2: Placebo Comparator

three identical placebo capsules twice daily which contained olive oil esters.

Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)

Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.

Detailed Description:

Despite some positive findings from observational and animal studies, the effects of n-3 PUFA administration on cognitive impairment in humans have received little evaluation to date. Although some clinical trials of fish oil have been reported, the results are inconsistent. Given these inconsistent findings, we carried out a preliminary study to investigate the effect of fish oil monotherapy on cognitive function and general clinical condition in patients with cognitive impairment.

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

fulfilled the diagnosis of AD according to the American Psychiatric Association, DSM-IV criteria, with mild or moderate severity( defined by an Mini Mental Status Examination (MMSE) score between 10 and 26, and a Clinical Dementia Rating (CDR) score of 1 or 2.)
or amnesic MCI( defined as (1). Subjective memory impairment by the patient and /or an informant, (2) objective memory impairment falling at least 1.5 standard deviations or more below age- and education-specific norms on the Logical Memory delayed-recall score from the Wechsler Memory Scale III (3) relatively normal performance in other cognitive domains, (4) no impairment in activities of daily living, and (5) failure to meet DSM-IV criteria for dementia.)

Exclusion Criteria:

inadequate motor or sensory capacity to comply with testing
any ischemic lesion on brain CT reported by the radiologist or a modified Hachinski Ischemic Scale score >4
a 17-item Hamilton Depression Scale (HDRS)score > 13
abnormal levels of folic acid, vitamin B12, or thyroid function
severe comorbidity, including another neurodegenerative diseases, another chronic debilitating neurological illness (e.g. cerebral palsy), brain trauma, tumors, severe pulmonary, renal, liver disease, cardiac disease, or autoimmune disease, or conditions expected to cause death within one year.
Participants with a diagnosis of alcoholism, schizophrenia, and bipolar disorder were excluded.
Participants receiving cholinesterase agents during the screen or taking NSAID on a long-term basis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628017

Locations

Taiwan
Taipei City Psychiatric Center, Taipei City Hospital
Taipei, Taiwan, 110

Sponsors and Collaborators

Taipei City Psychiatric Center, Taiwan

Department of Health, Taiwan

Investigators

Principal Investigator:	Chih-Chiang Chiu, M.D.	Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, Taiwan
Principal Investigator:	Shih-Yi Huang, PhD.	School of Nutrition and Health Sciences, Taipei Medical University, Taiwan

More Information

The Government Research Bulletin of Taiwan This link exits the ClinicalTrials.gov site

Responsible Party:	Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital ( Chih-Chiang Chiu, M.D. )
Study ID Numbers:	DOH-92-TD-1095
Study First Received:	February 24, 2008
Last Updated:	February 24, 2008
ClinicalTrials.gov Identifier:	NCT00628017
Health Authority:	Taiwan: Department of Health

Keywords provided by Taipei City Psychiatric Center, Taiwan:

polyunsaturated fatty acids
Alzheimer's disease
mild cognitive impairment
fish oil
cognition

Study placed in the following topic categories:

Tocopherol acetate
Hydroquinone
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders

Alpha-Tocopherol
Tocopherols
Vitamin E
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009