Preliminary Study of Fish Oil and Dementia
Primary Purpose
Alzheimer's Disease, Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
omega-3 polyunsaturated fatty acids ( EPA+DHA)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring polyunsaturated fatty acids, Alzheimer's disease, mild cognitive impairment, fish oil, cognition
Eligibility Criteria
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
Sites / Locations
- Taipei City Psychiatric Center, Taipei City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
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
three identical placebo capsules twice daily which contained olive oil esters.
Outcomes
Primary Outcome Measures
the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)
the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)
Secondary Outcome Measures
Mini Mental Status Examination (MMSE) scores
17-item Hamilton Depression Scale (HDRS)
adverse events
Full Information
NCT ID
NCT00628017
First Posted
February 24, 2008
Last Updated
February 24, 2008
Sponsor
Taipei City Psychiatric Center, Taiwan
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)
1. Study Identification
Unique Protocol Identification Number
NCT00628017
Brief Title
Preliminary Study of Fish Oil and Dementia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei City Psychiatric Center, Taiwan
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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:
general clinical impression
cognitive function
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
polyunsaturated fatty acids, Alzheimer's disease, mild cognitive impairment, fish oil, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
three identical placebo capsules twice daily which contained olive oil esters.
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 polyunsaturated fatty acids ( EPA+DHA)
Other Intervention Name(s)
fish oil, n3 fatty acids
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)
Time Frame
24 weeks
Title
the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mini Mental Status Examination (MMSE) scores
Time Frame
24 weeks
Title
17-item Hamilton Depression Scale (HDRS)
Time Frame
24 weeks
Title
adverse events
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Chiang Chiu, M.D.
Organizational Affiliation
Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shih-Yi Huang, PhD.
Organizational Affiliation
School of Nutrition and Health Sciences, Taipei Medical University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei City Psychiatric Center, Taipei City Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Preliminary Study of Fish Oil and Dementia
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