Back to results

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)

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

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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

We'll reach out to this number within 24 hrs