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”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2005

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.

Intervention(s) in this Clinical Trial

• 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, Groups and Cohorts in this Clinical Trial

• 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
• Placebo Comparator: 2
  • three identical placebo capsules twice daily which contained olive oil esters.

Primary Measures

• the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)
  • Time Frame: 24 weeks
    Safety Issue?: No
• the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• Mini Mental Status Examination (MMSE) scores
  • Time Frame: 24 weeks
    Safety Issue?: No
• 17-item Hamilton Depression Scale (HDRS)
  • Time Frame: 24 weeks
    Safety Issue?: No
• adverse events
  • Time Frame: 24 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Taipei City Psychiatric Center, Taiwan

Overall Clinical Trial Officials and Contacts

Chih-Chiang Chiu, M.D. Principal Investigator Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, Taiwan  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00628017

Study ID Number: DOH-92-TD-1095

ClinicalTrials.gov Identifier: NCT00628017

Health Authority: Taiwan: Department of Health

The Government Research Bulletin of Taiwan