Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects
Brief Summary: Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

* To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
* To study the long-term safety and tolerability of V0137,
* To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

* To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
* To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
* To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
* To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)


Options:
A: Inclusion Criteria:

* Subjects with peripheral arterial disease for more than 6 months.
* Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures\< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.
* Over 40 years old
* Able to comply with protocol requirements
* Able to provide informed consent
* Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.
* Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.

Exclusion Criteria:

* Patients with ischemic rest pain in limbs, ulceration, or gangrene.
* At baseline, any condition that prevents walking on a treadmill.
* History of major bleeding.
* Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).
* Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF\<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures).
* Moderate to severe renal failure.
* Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.
* Fish limitations (no more than 2 fish meals per week)
* Gluten allergy
* Subjects with allergies to any ingredient in the study product or placebo.
* Patients who plan to undergo surgery during the course of the trial.
B: Inclusion Criteria:

* subjects of both sex, aged of 70 years or over,
* subjects with at least one of the following frailty criteria: a subjective memory complaint, expressed to their attending physician, an inability to perform one of instrumental activities of daily living, a slow walking with a speed ≤ 0.77 m/s, i.e 5 seconds to walk 4 meters.
* subjects with an MMSE score of greater than or equal to 24,
* subjects capable of understanding the protocol, complying with its requirements and attending the study visits,
* subjects with sufficient availability to take part in the multi-domain intervention programme,
* subjects who, in the opinion of the investigator, are liable to comply with the treatment during the study;
* subjects capable of giving their written informed consent
* Covered by a health insurance system

Exclusion Criteria:

* Criteria related to diseases:

  * known presence of dementia or Alzheimer's disease (DSM IV criteria),
  * deterioration in global cognitive function (MMSE \< 24),
  * dependency for basic activities of daily living (ADL\<6),
  * presence of serious diseases, which could be life-threatening in the short term,
  * history or presence of any disease that could compromise the subject's participation in the multi-domain intervention sessions,
* Criteria related to treatments:

  o 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 pathologies 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 freedom by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution,
  * participation in another clinical study in the previous month or participation scheduled during the study.
C: Inclusion Criteria:

* Multiple risk factors:

  * diabetes,
  * age =\> 65 years,
  * male sex,
  * hypertension,
  * hypercholesterolemia,
  * smoking,
  * obesity,
  * family history of premature cardiovascular disease;
* Previous manifestations of atherosclerotic disease (ischemic stoke, transient ischemic attack \[TIA\], peripheral artery disease, previous arterial revascularisation procedures, angina pectoris)

Exclusion Criteria:

* Contraindications (known allergies to n-3 PUFA) or indications (previous myocardial infarction) for the treatment with n-3 PUFA
* Serious comorbidity with an unfavourable prognosis over the short term
* Expected non compliance over a long period of time
* Pregnancy
D: Inclusion Criteria:

* Clinical evidence of heart failure according to the European Society of Cardiology guidelines (New York Heart Association class II-IV) (32)
* Any left ventricular Ejection Fraction (EF) measured within 3 months from enrolment (if EF% \>40%, at least 1 hospital admission for Congestive Heart Failure(CHF) in the previous year)
* No age limits
* Any etiology
* Informed consent (obtained before any study specific procedure)

Exclusion Criteria:

COMMON EXCLUSION CRITERIA (R1=n-3 PUFA vs placebo and R2=rosuvastatin vs placebo):

* Acute Myocardial Infarction, unstable angina or revascularization procedure within 1 month;
* planned cardiac surgery, expected to be performed within 3 months;
* congenital or primary valvular etiology;
* known hypersensitivity to study treatments;
* significant liver disease;
* pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception;
* any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol;
* presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy;
* treatment with any investigational agent within 1 month before randomization;
* patients already on treatment with n-3 PUFA or statin for whom the prescription is confirmed.

EXCLUSION CRITERIA FOR R2 (statin hypothesis):

* current serum creatinine level \>2.5 mg/dL;
* current ALT, AST level \>1.5 times the upper normal limit;
* current CPK upper normal limits.

Answer: B