Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells (LO-MAPT)
Alzheimer Disease
About this trial
This is an interventional prevention trial for Alzheimer Disease focused on measuring Low OMega 3, Preventive trial, low RBC DHA/EPA index
Eligibility Criteria
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- University Hospital Toulouse
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Omega-3 treatment
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
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).