Multimodal Preventive Trial for Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer Disease; Prodromal
• Interventions: Other: Regular health advice; Behavioral: Multidomain lifestyle; Dietary Supplement: Medical food

• Registration Number: NCT03249688
• Lead Sponsor: Karolinska Institutet

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Study Start: 2017-10-16
• Primary Completion: 2019-12-23
• Study Completion: 2020-12-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Regular health advice	Regular health advice
Multidomain 2	Medical food	Multidomain lifestyle + medical food
Multidomain 1	Multidomain lifestyle	Multidomain lifestyle
Multidomain 2	Multidomain lifestyle	Multidomain lifestyle + medical food

Primary Outcome Measures

Name	Time	Method
Recruitment rate	6 months	Recruitment rate of participants within a 6 months period
Overall adherence to the intervention	6 months	Overall adherence to the intervention during 6 months
Retention rate	6 months	Retention rate of participants during 6 months

Secondary Outcome Measures

Name	Time	Method
Adherence to intervention components	6 months	Intervention arms only
Adherence to healthy lifestyle changes	6 months	All arms

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Huddinge, Sweden