Brain DHA Delivery and Alzheimer's Disease RiskPhase 2PreventE4NCT03613844
DHA Brain Delivery Trial
A Phase 2 study testing DHA in people with Brain DHA Delivery and Alzheimer's Disease Risk, run by University of Southern California at 1 site in United States.
Trial summary
Carrying the APOE ɛ4 allele is the strongest genetic risk factor for developing Alzheimer's disease. The goal of this project is to identify whether carrying the APOE ɛ4 allele is associated with reduced delivery of DHA to the brain. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain DHA Delivery and Alzheimer's Disease Risk
- What is being tested?
- DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 16 May 2024
- Phase
- Phase 2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥ 55 and ≤ 80
- At least one dementia risk factor (obesity, education years, hypertension, hyperlipidemia)
- Mini-Mental State Examination (MMSE) ≥ 25
- Logical Memory II delayed recall score ≥ 6 and ≤ 18 .
Who cannot join
- Diagnosis of dementia as assessed by the investigator
- Use of omega-3 preparations in the last 3 months
- > 200 mg/day of DHA consumption using a validated questionnaire
- Use of donepezil, rivastigmine, galantamine and/or memantine
- Alcohol or drug abuse
- A concomitant serious disease such as active cancer treatment or HIV.
- Participation in a clinical trial in the last 30 days
- Use of anticoagulants such as Plavix or Coumadin or the newer generation blood thinners.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Keck School of Medicine
Los Angeles, California, 90033
About this study
Official title: The Delivery of Essential Fatty Acids to the Brain
Carrying the APOE ɛ4 allele is the strongest genetic risk factor for developing Alzheimer's disease. The goal of this project is to identify whether carrying the APOE ɛ4 allele is associated with reduced delivery of DHA to the brain. This information will help us identify the target population that could benefit from DHA supplementation to prevent cognitive decline.
Read the detailed description
The Brain DHA Delivery Trial will examine the effect of APOE genotype on the changes of cerebrospinal fluid (CSF) DHA to Arachidonic acid (AA) ratio in 184 cognitively healthy older individuals in response to DHA supplementation. Randomized clinical trials have yielded mixed results on the effect DHA supplementation on cognitive outcomes. This study asks the critical question of whether DHA gets into the brain in sufficient amounts after supplementation, and whether APOE genotype affects brain penetrance.
This trial will also test the effect of DHA supplementation on changes in brain structural and functional connectivity assessed by MRI, and changes in cognition after two years of supplementation in all 368 participants.
- Being tested
- DHA, Placebo
- Keywords
- Alzheimer's disease, Docosahexaenoic Acids, Apolipoprotein E4
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADrug
DHA supplementation
PlaceboDrug
Placebo for DHA
| Study group | Role | What they receive |
|---|---|---|
| DHA | Experimental | oral DHA supplementation at 2 grams per day Receives: Drug: DHA |
| Placebo | Placebo comparator | Placebo for DHA Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
cerebrospinal fluid fatty acids assessed by mass spectrometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Sep 2018
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain DHA Delivery and Alzheimer's Disease RiskStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind and randomized placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Huntington Medical Research Institutes, National Institute on Aging (NIA), Alzheimer's Drug Discovery Foundation
- Responsible party
- Principal investigator, Hussein Yassine, University of Southern California
- Investigators
- Hussein Yassine, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613844
- Sponsor's protocol ID
- HS-18-00291/00984
- Other IDs
- R01AG054434, GC-201711-2014197
- Acronym
- PreventE4
- Status last verified
- Jun 2024
- First submitted
- 11 Jul 2018
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: available by request to study principal investigator and after approval by study committee.
Publications
Yassine HN, Braskie MN, Mack WJ, Castor KJ, Fonteh AN, Schneider LS, Harrington MG, Chui HC. Association of Docosahexaenoic Acid Supplementation With Alzheimer Disease Stage in Apolipoprotein E epsilon4 Carriers: A Review. JAMA Neurol. 2017 Mar 1;74(3):339-347. doi: 10.1001/jamaneurol.2016.4899.
PubMed 28114437Yassine HN, Arellanes IC, Mazmanian A, De La Cruz L, Martinez J, Contreras L, Kono N, Liu BS, Badie D, Bantugan MA, Grindon A, Urich T, D'Orazio L, Emmanuel BA, Chui HC, Mack WJ, Harrington MG, Braskie MN, Schneider LS. Baseline Findings of PreventE4: A Double-Blind Placebo Controlled Clinical Trial Testing High Dose DHA in APOE4 Carriers before the Onset of Dementia. J Prev Alzheimers Dis. 2023;10(4):810-820. doi: 10.14283/jpad.2023.77.
PubMed 37874103
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Delivery of Essential Fatty Acids to the Brain
- ClinicalTrials.gov ID
- NCT03613844
- Acronym / sponsor ID
- PreventE4 / HS-18-00291/00984
- Keywords
- Alzheimer's disease, Docosahexaenoic Acids, Apolipoprotein E4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Huntington Medical Research Institutes, National Institute on Aging (NIA), Alzheimer's Drug Discovery Foundation
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 3 Aug 2018 (actual)
- 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.
Carrying the APOE ɛ4 allele is the strongest genetic risk factor for developing Alzheimer's disease. The goal of this project is to identify whether carrying the APOE ɛ4 allele is associated with reduced delivery of DHA to the brain. This information will help us identify the target population that could benefit from DHA supplementation to prevent cognitive decline.
Detailed description
The Brain DHA Delivery Trial will examine the effect of APOE genotype on the changes of cerebrospinal fluid (CSF) DHA to Arachidonic acid (AA) ratio in 184 cognitively healthy older individuals in response to DHA supplementation. Randomized clinical trials have yielded mixed results on the effect DHA supplementation on cognitive outcomes. This study asks the critical question of whether DHA gets into the brain in sufficient amounts after supplementation, and whether APOE genotype affects brain penetrance.
This trial will also test the effect of DHA supplementation on changes in brain structural and functional connectivity assessed by MRI, and changes in cognition after two years of supplementation in all 368 participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind and randomized placebo controlled
| Arm | Type | Receives |
|---|---|---|
| DHA | Experimental | Drug: DHAoral DHA supplementation at 2 grams per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for DHA |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥ 55 and ≤ 80
- At least one dementia risk factor (obesity, education years, hypertension, hyperlipidemia)
- Mini-Mental State Examination (MMSE) ≥ 25
- Logical Memory II delayed recall score ≥ 6 and ≤ 18 .
Key exclusion criteria (8 listed)
- Diagnosis of dementia as assessed by the investigator
- Use of omega-3 preparations in the last 3 months
- > 200 mg/day of DHA consumption using a validated questionnaire
- Use of donepezil, rivastigmine, galantamine and/or memantine
- Alcohol or drug abuse
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 |
|---|---|---|
| DHADHA supplementation | Drug | DHA |
| PlaceboPlacebo for DHA | Drug | Placebo |
Primary outcome
change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
Time frame: 6 months
cerebrospinal fluid fatty acids assessed by mass spectrometry
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 7 Jun 2024.
- Background: PubMed 28114437Yassine HN, Braskie MN, Mack WJ, Castor KJ, Fonteh AN, Schneider LS, Harrington MG, Chui HC. Association of Docosahexaenoic Acid Supplementation With Alzheimer Disease Stage in Apolipoprotein E epsilon4 Carriers: A Review. JAMA Neurol. 2017 Mar 1;74(3):339-347. doi: 10.1001/jamaneurol.2016.4899.
- Derived from this study: PubMed 37874103Yassine HN, Arellanes IC, Mazmanian A, De La Cruz L, Martinez J, Contreras L, Kono N, Liu BS, Badie D, Bantugan MA, Grindon A, Urich T, D'Orazio L, Emmanuel BA, Chui HC, Mack WJ, Harrington MG, Braskie MN, Schneider LS. Baseline Findings of PreventE4: A Double-Blind Placebo Controlled Clinical Trial Testing High Dose DHA in APOE4 Carriers before the Onset of Dementia. J Prev Alzheimers Dis. 2023;10(4):810-820. doi: 10.14283/jpad.2023.77.
- Individual participant dataSharing planned: Yes. available by request to study principal investigator and after approval by study committee.
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.
Hussein Yassine, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DHA in people with Brain DHA Delivery and Alzheimer's Disease Risk, run by University of Southern California at 1 site 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 8 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 7 Jun 2024. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects (time frame: 6 months). 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 NCT03613844, which also lists 2 linked publications.
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 7 Jun 2024.