Multimodal Preventive Trial for Alzheimer's Disease
Condition: Alzheimer Disease; Prodromal
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The main aim of the MIND-ADmini pilot trial is to evaluate the feasibility of a multimodal
      lifestyle intervention among patients with prodromal AD.
    

Detailed description: 
      Given the multifactorial etiology of Alzheimer's disease (AD), multimodal interventions
      targeting several risk factors and disease mechanisms simultaneously are most likely to be
      effective for preventing dementia. Multimodal lifestyle interventions have so far been tested
      in at-risk older adults from the general population, but not in patients with prodromal AD.

      The main aim of the MIND-ADmini pilot trial is to evaluate the feasibility of a multimodal
      lifestyle intervention among individuals with prodromal AD.

      This 6-month pilot trial is planned to include 150 participants randomized into 3 arms:

        1. Control (regular health advice)

        2. Multidomain lifestyle intervention (nutritional guidance, exercise, cognitive training
           and monitoring and management of vascular and metabolic risk factors)

        3. Multidomain lifestyle intervention + medical food. The multidomain lifestyle
           intervention is adapted from the Finnish Geriatric Intervention Study to Prevent
           Cognitive Impairment and Disability (FINGER, NCT01041989). The medical food product
           includes the specific multi-nutrient combination Fortasyn Connect (containing the
           omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), uridine
           monophosphate, choline, vitamins B12, B6, C, E, and folic acid, phospholipids, and
           selenium). The rationale for combining a multidomain lifestyle intervention with medical
           food is evidence indicating synergistic effects between different intervention
           components (e.g. omega-3 fatty acids and physical activity). Nutrient deficiencies have
           been described in AD, and medical food may be needed in addition to dietary guidance for
           optimal effect. The use of Fortasyn Connect alone in prodromal AD has been investigated
           in another clinical trial (www.lipididiet.eu), and thus this arm is not included in
           MIND-ADmini.

      The 6-month MIND-ADmini pilot trial will be conducted in Sweden, Finland, Germany and France.
      An additional 6-month optional extension of the pilot trial will also be considered.

      Primary outcome is feasibility of the multimodal intervention. Secondary outcomes include
      adherence to intervention components (intervention arms), and adherence to healthy lifestyle
      changes (all arms). Detailed cognitive assessments (Neuropsychological Test Battery, NTB) and
      functional assessments (Clinical Dementia Rating, CDR; and Alzheimer's Disease Cooperative
      Study-Activities of Daily Living, ADCS-ADL) will also be conducted at baseline and 6-month
      visit for the purpose of obtaining reliable estimates of change over time for power
      calculations for a future larger multimodal intervention trial (MIND-ADmaxi).
    

Intervention name(s): Regular health advice; Multidomain lifestyle; Medical food
Intervention type(s): Other; Behavioral; Dietary Supplement
Intervention description(s): Routine healthy lifestyle counseling; Nutritional guidance, exercise, cognitive training, vascular risk monitoring; Medical food product (Fortasyn Connect)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lifestyle intervention; Medical food; Randomized controlled trial; Prodromal Alzheimer's disease; Prevention; Intervention; Multidomain; Multimodal