Preliminary Study of Fish Oil and Dementia

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628017
• Other study ID #: DOH-92-TD-1095
• Status: Completed
• Phase: N/A
• First received: February 24, 2008
• Last updated: February 24, 2008
• Start date: January 2003
• Est. completion date: March 2005

Study information

• Verified date: February 2008
• Source: Taipei City Psychiatric Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei City Psychiatric Center, Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Psychiatric Center, Taiwan	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)		24 weeks	No
Primary	the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)		24 weeks	No
Secondary	Mini Mental Status Examination (MMSE) scores		24 weeks	No
Secondary	17-item Hamilton Depression Scale (HDRS)		24 weeks	No
Secondary	adverse events		24 weeks	Yes

External Links

•   The Government Research Bulletin of Taiwan