Preliminary Study of Fish Oil and Dementia

The Effects of Omega-3 Fatty Acids Monotherapy in Alzheimer's Disease and Mild Cognitive Impairment: a Preliminary Randomized Double-Blind Placebo-Controlled Study

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:

1. general clinical impression
2. cognitive function

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Dietary supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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.; Other Names: fish oil; n3 fatty acids
Placebo Comparator: 2; 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.; Other Names: fish oil; n3 fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)	24 weeks
the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mini Mental Status Examination (MMSE) scores	24 weeks
17-item Hamilton Depression Scale (HDRS)	24 weeks
adverse events	24 weeks

Collaborators and Investigators

• Sponsor: Taipei City Psychiatric Center, Taiwan
• Collaborators: Department of Health, Executive Yuan, R.O.C. (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

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: February 24, 2008
• First Submitted That Met QC Criteria: February 24, 2008
• First Posted (Estimate): March 4, 2008

Study Record Updates

• Last Update Posted (Estimate): March 4, 2008
• Last Update Submitted That Met QC Criteria: February 24, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Alzheimer's disease; cognition; mild cognitive impairment; polyunsaturated fatty acids; fish oil
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: DOH-92-TD-1095