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 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.
B: Inclusion Criteria:

* Aged 80 or older
* Sitting systolic BP 160-199 mmHg AND sitting diastolic BP \< 110 mmHg

Exclusion Criteria:

* Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema).
* Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only.
* Renal failure (serum creatinine of more than 150 µmol/l).
* Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.)
* Condition expected to severely limit survival, e.g. terminal illness.
* Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause).
* Gout.
* Clinical diagnosis of dementia.
* Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable).
* Unable to stand up or walk
* Participation in a drug trial within the past month preceding selection.
* Alcohol or drug abuse.
* Less than 2 months placebo run-in.
* Contraindications to use of trial drugs
C: Inclusion Criteria:

* Aged 70 years or older.
* Family history of parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.
* Study partner available to provide information on the cognitive status of the participant and to assist with monitoring of trial medications, if needed.
* Sufficient fluency in written and spoken English to participate in study visits and neuropsychological testing.
* Willingness to limit use of the following for the duration of the study: vitamin E (at doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts
* Ability and intention to participate in regular study visits, in the opinion of the study physician.
* Provision of informed consent.

Exclusion Criteria:

* History of peptic ulcer disease with bleeding or obstruction.
* Clinically significant liver or kidney disease.
* History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs.
* Use of anti-coagulant medication.
* Cognitive impairment or dementia.
* Current alcohol abuse or dependence
D: Inclusion Criteria:

* At least 50 years old

Systolic blood pressure of

* 130 - 180 mm Hg on 0 or 1 medication
* 130 - 170 mm Hg on up to 2 medications
* 130 - 160 mm Hg on up to 3 medications
* 130 - 150 mm Hg on up to 4 medications

Risk (one or more of the following)

1. Presence of clinical or subclinical cardiovascular disease other than stroke
2. CKD, defined as eGFR 20 - 59 ml/min/1.73m2
3. A Framingham Risk Score for 10-year CVD risk ≥ 15%
4. Age greater than 75 years

Exclusion Criteria:

* An indication for a specific BP lowering medication that the person is not taking and the person has not been documented to be intolerant of the medication class.
* Known secondary cause of hypertension that causes concern regarding safety of the protocol.
* One minute standing SBP \< 110 mm Hg.
* Proteinuria in the following ranges (based on a measurement within the past 6 months)

  * 24 hour urinary protein excretion ≥1 g/day, or
  * 24 hour urinary albumin excretion ≥ 600 mg/day, or
  * spot urine protein/creatinine ratio ≥ 1 g/g creatinine, or
  * spot urine albumin/creatinine ratio ≥ 600 mg/g creatinine, or
  * urine dipstick ≥ 2+ protein
* Arm circumference too large or small to allow accurate blood pressure measurement with available devices
* Diabetes mellitus,
* History of stroke (not CE or stenting)
* Diagnosis of polycystic kidney disease
* Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
* eGFR \< 20 ml/min /1.73m2 or end-stage renal disease (ESRD)
* Cardiovascular event or procedure (as defined above as clinical CVD for study entry) or hospitalization for unstable angina within last 3 months
* Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) \< 35%
* A medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 years
* Any factors judged by the clinic team to be likely to limit adherence to interventions.
* Failure to obtain informed consent from participant
* Currently participating in another clinical trial (intervention study). Note: Patient must wait until the completion of his/her activities or the completion of the other trial before being screened for SPRINT.
* Living in the same household as an already randomized SPRINT participant
* Any organ transplant
* Unintentional weight loss \> 10% in last 6 months
* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control.

Answer: A