Alzheimer's DiseaseNCT00628017
Preliminary Study of Fish Oil and Dementia
A study testing omega-3 polyunsaturated fatty acids ( EPA+DHA) in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Taipei City Psychiatric Center, Taiwan at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- omega-3 polyunsaturated fatty acids ( EPA+DHA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2003to Mar 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- omega-3 polyunsaturated fatty acids ( EPA+DHA)
- Keywords
- polyunsaturated fatty acids, Alzheimer's disease, mild cognitive impairment, fish oil, cognition
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 polyunsaturated fatty acids ( EPA+DHA)Dietary supplement
Also called fish oil, n3 fatty acids
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA) |
| 2 | Placebo comparator | three identical placebo capsules twice daily which contained olive oil esters. Receives: Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)
Measured: 24 weeks
the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)
Measured: 24 weeks
Secondary outcomes (3)
Mini Mental Status Examination (MMSE) scores
Measured: 24 weeks
17-item Hamilton Depression Scale (HDRS)
Measured: 24 weeks
adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startJan 2003
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Psychiatric Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Investigators
- Chih-Chiang Chiu, M.D., Principal investigator, Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, TaiwanShih-Yi Huang, PhD., Principal investigator, School of Nutrition and Health Sciences, Taipei Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628017
- Sponsor's protocol ID
- DOH-92-TD-1095
- Status last verified
- Feb 2008
- First submitted
- 24 Feb 2008
- Last updated
- 4 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00628017
- Acronym / sponsor ID
- DOH-92-TD-1095
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- polyunsaturated fatty acids, Alzheimer's disease, mild cognitive impairment, fish oil, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taipei City Psychiatric Center, TaiwanUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Jan 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 4 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)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 |
| 2 | Placebo comparator | Dietary Supplement: omega-3 polyunsaturated fatty acids ( EPA+DHA)three identical placebo capsules twice daily which contained olive oil esters. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 polyunsaturated fatty acids ( EPA+DHA)Also: fish oil, n3 fatty acidsGroup 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. | Dietary supplement | 1, 2 |
Primary outcome
the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)
Time frame: 24 weeks
the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)
Time frame: 24 weeks
3 secondary outcomes
Mini Mental Status Examination (MMSE) scores
Time frame: 24 weeks
17-item Hamilton Depression Scale (HDRS)
Time frame: 24 weeks
adverse events
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Chiang Chiu, M.D. principal investigator
Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, Taiwan
Shih-Yi Huang, PhD. principal investigator
School of Nutrition and Health Sciences, Taipei Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 polyunsaturated fatty acids ( EPA+DHA) in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Taipei City Psychiatric Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.