Alzheimer DiseasePhase 3LO-MAPTNCT03691519
Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells
A Phase 3 study testing Omega-3 treatment in people with Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
LO MAPT is an 18-month, phase III, multicenter, randomized, placebo-controlled, 2 parallel groups trial, followed by a 18-month open-label extension phase, to evaluate the efficacy of omega-3 supplementation on cognitive decline in older adults with low DHA/EPA status and subjective memory complaints or family history… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Omega-3 treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 774 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2018to 31 Mar 2020
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- RBC DHA/EPA index ≤ 4.83% with at least one of the following criteria:
- subjective memory complaint,
- family history of Alzheimer's disease;
- Mini-Mental State Examination (MMSE) score ≥ 24;
- Have a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in person, via telephone or electronic communication);
- Sufficient vision and hearing to complete study protocol procedures based on medical judgment;
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- Have general health status that will not interfere with the ability to complete the study;
- Willing and able to participate and to give written consent to comply with study procedures;
- Covered by a health insurance system.
Who cannot join
- Criteria related to diseases:
- Known presence of dementia or Alzheimer's disease (DSMIV criteria);
- Dependency for basic activities of daily living (ADL score <4);
- Presence of serious diseases, which could be life-threatening in the short term.
- Criteria related to treatments:
- Taking of supplements containing omega-3 (apart from food) within the past 6 months and/or taking omega-3 at inclusion.
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- Criteria related to subjects:
- Visual or hearing impairments incompatible with performance and/or interpretation of the neuropsychological tests;
- History or presence of any previous condition (severe depression or generalized anxiety) that could, in the opinion of the investigator, interfere with the results of the study or expose the subject to an additional risk;
- Subjects deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited);
- Participation in another clinical study in the previous month or participation scheduled during the study;
- Food allergy.
Trial locations and contacts
1 site in 1 country.
About this study
LO MAPT is an 18-month, phase III, multicenter, randomized, placebo-controlled, 2 parallel groups trial, followed by a 18-month open-label extension phase, to evaluate the efficacy of omega-3 supplementation on cognitive decline in older adults with low DHA/EPA status and subjective memory complaints or family history of Alzheimer disease.
Read the detailed description
LO-MAPT will also assess the effect of an audiovisual aid, compared with traditional paper participant information sheet only, on participants' understanding of the protocol, as well as on drop-out, adherence and clinical outcome in older adults at risk of cognitive decline. In addition to the main LO-MAPT study procedures, in two centers, half of the subjects will receive an audiovisual aid in addition to the standard information sheet.
The primary objective of LO MAPT is to demonstrate the efficacy of a 18-month intervention with a supplementation of omega-3 (DHA+EPA) on cognitive decline as measured by a composite score of neuropsychological assessments in older adults with low DHA/EPA status (RBC DHA/EPA index ≤ 4.83%) and subjective memory complaints or family history of Alzheimer's disease.
Subjects will be randomly assigned in a 1:1 ratio to one of the following 2 groups: (i) DHA+EPA supplement or (ii) placebo. A computer-generated randomisation procedure will be used with stratification by centre. A centralised Interactive Voice Response System will be used to identify which group to allocate and which lot number to administer. A document describing the randomization procedure will be kept confidentially by the Methodology and Data Management Centre. All participants and study staff will be blinded to DHA+EPA supplement/placebo assignment: all participants will receive soft capsules of exactly the same appearance and taste.
- Conditions
- Alzheimer Disease
- Being tested
- Omega-3 treatment, Placebo
- Keywords
- Low OMega 3, Preventive trial, low RBC DHA/EPA index
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 treatmentDrug
Also called Dietary intervention
Patient in the "treatment comparative arm will consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day).
PlaceboDietary supplement
The appearance and taste of the placebo will be similar to those of the active ingredient. Placebo capsules contained a 1:1 ratio of corn oil and soy oil.
36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment. Active treatment consists of 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day).
For the 18 months placebo-controlled period (n=200/arm): 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day) or placebo (3 similar pills /day).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | During the 18 months placebo-controlled period, participants will ask to consume 3 identical 1g vegetarian control capsules (containing a 1:1 ratio of corn oil and soy oil) per day. During the following 18-month open-label extension period, placebo subjects are switched to active treatment.
36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment Receives: Dietary Supplement: Placebo |
| Omega-3 treatment | Experimental | During the entire length of the study (that is, both the placebo-controlled and open-label extension periods), participants in the intervention (Omega-3 treatment) arm will ask to consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day). Receives: Drug: Omega-3 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Composite Z-score which evaluate cognitive performance
This composite score will be built of Z-scores of these components. As this criterion will be assessed during each visit (the enrolment visit and the 4 follow-up visits), the analysis will be carried out by taking repeat measurements, taking the correlated of the data into consideration, evaluating Change from Baseline
Measured: 18 months
Secondary outcomes (3)
FCSRT Test
Tests included in the composite score will be analyzed independently The Free and Cued Selective Reminding test (FCSRT) is a memory test that controls attention and acquisition : Verbal learning with 16-word free and indexed recall test. Each word is identified by a semantic category. Word encoding is controlled. The total learning score is equal to the sum of the free and indexed recall. The maximum score is 48.
Measured: 18 months
MMSE total score
MMSE (MINI MENTAL STATE EXAMINATION) total score : 30-question general cognitive function assessment. The maximum score is 30.
Measured: 18 months
Category Naming Test (CNT)
The CNT is a semantic verbal fluency test which assesses spontaneous production of words belonging to the same category within a certain time (i.e. the animal category).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start17 Apr 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned in a 1:1 ratio to one of the following 2 groups: (i) DHA+EPA supplement or (ii) placebo. A computer-generated randomisation procedure will be used with stratification by centre. A centralised Interactive Voice Response System will be used to identify which group to allocate and which lot number to administrate
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Vellas, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691519
- Sponsor's protocol ID
- RC31/16/8752
- Other IDs
- 2016-A01450-51
- Acronym
- LO-MAPT
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2018
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells
- ClinicalTrials.gov ID
- NCT03691519
- Acronym / sponsor ID
- LO-MAPT / RC31/16/8752
- Conditions
- Alzheimer Disease
- Keywords
- Low OMega 3, Preventive trial, low RBC DHA/EPA index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Oct 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.
LO MAPT is an 18-month, phase III, multicenter, randomized, placebo-controlled, 2 parallel groups trial, followed by a 18-month open-label extension phase, to evaluate the efficacy of omega-3 supplementation on cognitive decline in older adults with low DHA/EPA status and subjective memory complaints or family history of Alzheimer disease.
Detailed description
LO-MAPT will also assess the effect of an audiovisual aid, compared with traditional paper participant information sheet only, on participants' understanding of the protocol, as well as on drop-out, adherence and clinical outcome in older adults at risk of cognitive decline. In addition to the main LO-MAPT study procedures, in two centers, half of the subjects will receive an audiovisual aid in addition to the standard information sheet.
The primary objective of LO MAPT is to demonstrate the efficacy of a 18-month intervention with a supplementation of omega-3 (DHA+EPA) on cognitive decline as measured by a composite score of neuropsychological assessments in older adults with low DHA/EPA status (RBC DHA/EPA index ≤ 4.83%) and subjective memory complaints or family history of Alzheimer's disease.
Subjects will be randomly assigned in a 1:1 ratio to one of the following 2 groups: (i) DHA+EPA supplement or (ii) placebo. A computer-generated randomisation procedure will be used with stratification by centre. A centralised Interactive Voice Response System will be used to identify which group to allocate and which lot number to administer. A document describing the randomization procedure will be kept confidentially by the Methodology and Data Management Centre. All participants and study staff will be blinded to DHA+EPA supplement/placebo assignment: all participants will receive soft capsules of exactly the same appearance and taste.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned in a 1:1 ratio to one of the following 2 groups: (i) DHA+EPA supplement or (ii) placebo. A computer-generated randomisation procedure will be used with stratification by centre. A centralised Interactive Voice Response System will be used to identify which group to allocate and which lot number to administrate
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDuring the 18 months placebo-controlled period, participants will ask to consume 3 identical 1g vegetarian control capsules (containing a 1:1 ratio of corn oil and soy oil) per day. During the following 18-month open-label extension period, placebo subjects are switched to active treatment. 36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment |
| Omega-3 treatment | Experimental | Drug: Omega-3 treatmentDuring the entire length of the study (that is, both the placebo-controlled and open-label extension periods), participants in the intervention (Omega-3 treatment) arm will ask to consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- RBC DHA/EPA index ≤ 4.83% with at least one of the following criteria:
- subjective memory complaint,
- family history of Alzheimer's disease;
- Mini-Mental State Examination (MMSE) score ≥ 24;
- Have a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in person, via telephone or electronic communication);
Key exclusion criteria (12 listed)
- Criteria related to diseases:
- Known presence of dementia or Alzheimer's disease (DSMIV criteria);
- Dependency for basic activities of daily living (ADL score <4);
- Presence of serious diseases, which could be life-threatening in the short term.
- Criteria related to treatments:
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 treatmentAlso: Dietary interventionPatient in the "treatment comparative arm will consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day). | Drug | Omega-3 treatment |
| PlaceboThe appearance and taste of the placebo will be similar to those of the active ingredient. Placebo capsules contained a 1:1 ratio of corn oil and soy oil. 36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment. Active treatment consists of 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day). For the 18 months placebo-controlled period (n=200/arm): 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day) or placebo (3 similar pills /day). | Dietary supplement | Placebo |
Primary outcome
Change from Baseline of Composite Z-score which evaluate cognitive performance
Time frame: 18 months
This composite score will be built of Z-scores of these components. As this criterion will be assessed during each visit (the enrolment visit and the 4 follow-up visits), the analysis will be carried out by taking repeat measurements, taking the correlated of the data into consideration, evaluating Change from Baseline
3 secondary outcomes
FCSRT Test
Time frame: 18 months
MMSE total score
Time frame: 18 months
Category Naming Test (CNT)
Time frame: 18 months
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 24 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Bruno Vellas, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 treatment in people with Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
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 9 inclusion and 12 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 24 Aug 2023. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 from Baseline of Composite Z-score which evaluate cognitive performance (time frame: 18 months). 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 24 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.