Status:
COMPLETED
Preliminary Study of Fish Oil and Dementia
Lead Sponsor:
Taipei City Psychiatric Center, Taiwan
Collaborating Sponsors:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Conditions:
Alzheimer's Disease
Mild Cognitive Impairment
Eligibility:
All Genders
55-90 years
Phase:
NA
Brief 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 wh...
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 cl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00628017
Start Date
January 1 2003
End Date
March 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
Taipei City Psychiatric Center, Taipei City Hospital
Taipei, Taiwan, 110