Age-Related Cognitive DeclineMIDASNCT00278135
Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
A study of Age-Related Cognitive Decline and Age-Related Memory Disorders, run by dsm-firmenich Switzerland AG at 14 sites in United States.
Trial summary
The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3) in improving cognitive functions in subjects with age-related cognitive decline. DHA is a long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual development and cardiovascular health. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Cognitive Decline, Age-Related Memory Disorders
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 485 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2005to Dec 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged 55 or greater.
- Have a subjective memory complaint and have a Logical Memory subtest (of the Wechsler Memory Scale - III [WMS-III]) raw score one standard deviation or greater below the mean of a younger population.
- Have the ability to understand the requirements of the study; be willing to provide written informed consent; and agree to abide by the study restrictions and return for the required assessments.
- If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).
Who cannot join
- Have a screening Mini-Mental State Examination (MMSE) < 26.
- Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnaire in the prior 2 months to screening.
- Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in the prior 2 months to screening.
- Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening.
- Use major anti-psychotics or major anti-depressants.
- Use lipase inhibitors such as Xenical® (orlistat).
Show all 11Show fewer
- History of major medical conditions including ischemic stroke, head trauma with loss of consciousness, epilepsy, psychosis, vascular dementia, depression (Geriatric Depression [15-item] > 5), myocardial infarction (within 1 year), uncontrolled diabetes, or blindness.
- History of major surgery within the past 6 months.
- Current use or history of drug and/or alcohol abuse within 5 years.
- Administration of any investigational product within the past 30 days.
- Inability to swallow capsules.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Neurological Research Center, Inc.
Bennington, Vermont, 05201
Bradenton Neurology
Bradenton, Florida, 34205
Radiant Research Chicago
Chicago, Illinois, 60610
Brain Matters Research
Delray Beach, Florida, 33445
Radiant Research Denver
Denver, Colorado, 80212
Clinical Trial Center
Jenkintown, Pennsylvania, 19046
Pivotal Research Center
Mesa, Arizona, 85210
Radiant Research Salt Lake City
Salt Lake City, Utah, 84107
Radiant Research San Antonio
San Antonio, Texas, 78229
Pacific Research Network
San Diego, California, 92103
Meridien Research
St. Petersburg, Florida, 33709
Stedman Clinical Trials
Tampa, Florida, 33613
Pacific Research Network
Vista, California, 92083
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly
The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3) in improving cognitive functions in subjects with age-related cognitive decline. DHA is a long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual development and cardiovascular health.
- Being tested
- DHA (nutritional supplement) or placebo
- Keywords
- Cognition, Memory, Nutrition, Omega-3, DHA
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA (nutritional supplement) or placeboDietary supplement
oral 900mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Dietary Supplement: DHA (nutritional supplement) or placebo |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: DHA (nutritional supplement) or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effects of DHA, a nutritional supplement (900 mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function) in healthy elderly subjects at 24 weeks
Measured: 24 weeks
Secondary outcomes (2)
Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered
Measured: 24 weeks
The study will include a screening period, baseline, and 24 week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Cognitive DeclineStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karin Yurko-Mauro, PhD, Study director, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278135
- Sponsor's protocol ID
- 2005.1002
- Acronym
- MIDAS
- Status last verified
- May 2014
- First submitted
- 13 Jan 2006
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Yurko-Mauro K, McCarthy D, Rom D, Nelson EB, Ryan AS, Blackwell A, Salem N Jr, Stedman M; MIDAS Investigators. Beneficial effects of docosahexaenoic acid on cognition in age-related cognitive decline. Alzheimers Dement. 2010 Nov;6(6):456-64. doi: 10.1016/j.jalz.2010.01.013.
PubMed 20434961
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly
- ClinicalTrials.gov ID
- NCT00278135
- Acronym / sponsor ID
- MIDAS / 2005.1002
- Keywords
- Cognition, Memory, Nutrition, Omega-3, DHA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Jan 2006 (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.
The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3) in improving cognitive functions in subjects with age-related cognitive decline. DHA is a long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual development and cardiovascular health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: DHA (nutritional supplement) or placebo |
| 2 | Placebo comparator | Dietary Supplement: DHA (nutritional supplement) or placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females, aged 55 or greater.
- Have a subjective memory complaint and have a Logical Memory subtest (of the Wechsler Memory Scale - III [WMS-III]) raw score one standard deviation or greater below the mean of a younger population.
- Have the ability to understand the requirements of the study; be willing to provide written informed consent; and agree to abide by the study restrictions and return for the required assessments.
- If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).
Key exclusion criteria (11 listed)
- Have a screening Mini-Mental State Examination (MMSE) < 26.
- Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnaire in the prior 2 months to screening.
- Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in the prior 2 months to screening.
- Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening.
- Use major anti-psychotics or major anti-depressants.
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 |
|---|---|---|
| DHA (nutritional supplement) or placebooral 900mg/day | Dietary supplement | 1, 2 |
Primary outcome
Determine the effects of DHA, a nutritional supplement (900 mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function) in healthy elderly subjects at 24 weeks
Time frame: 24 weeks
2 secondary outcomes
Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered
Time frame: 24 weeks
The study will include a screening period, baseline, and 24 week treatment period.
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 19 May 2014.
- Derived from this study: PubMed 20434961Yurko-Mauro K, McCarthy D, Rom D, Nelson EB, Ryan AS, Blackwell A, Salem N Jr, Stedman M; MIDAS Investigators. Beneficial effects of docosahexaenoic acid on cognition in age-related cognitive decline. Alzheimers Dement. 2010 Nov;6(6):456-64. doi: 10.1016/j.jalz.2010.01.013.
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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.
Karin Yurko-Mauro, PhD study director
dsm-firmenich Switzerland AG
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Age-Related Cognitive Decline and Age-Related Memory Disorders, run by dsm-firmenich Switzerland AG at 14 sites in United States.
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 4 inclusion and 11 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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?
Determine the effects of DHA, a nutritional supplement (900 mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function) in healthy elderly subjects at 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00278135, which also lists 1 linked publication.
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 19 May 2014.