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Completed

NCT Number: NCT00628017

Preliminary Study of Fish Oil and Dementia

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

Completed

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei City Psychiatric Center, Taipei City Hospital

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

omega-3 polyunsaturated fatty acids ( EPA+DHA)

Dietary Supplement

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

Primary outcomes

  1. the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)

    Time frame: 24 weeks

  2. the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)

    Time frame: 24 weeks

Secondary outcomes

  1. Mini Mental Status Examination (MMSE) scores

    Time frame: 24 weeks

  2. 17-item Hamilton Depression Scale (HDRS)

    Time frame: 24 weeks

  3. adverse events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Taipei City Psychiatric Center, Taiwan

Other

Collaborators

  • Department of Health, Executive Yuan, R.O.C. (Taiwan)

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Mar 4, 2008
Registry last updated
Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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