Multimodal Preventive Trial for Alzheimer's Disease: MIND-ADmini Pilot Trial Study Design and Progress

Area of Science:

• Neurology
• Gerontology
• Nutritional Science

Background:

• Multidomain interventions targeting multiple risk factors are key for preventing cognitive impairment.
• Previous studies like FINGER and LipiDiDiet highlight the potential of lifestyle interventions and medical food in at-risk individuals and early symptomatic Alzheimer's disease (AD).
• The feasibility of multimodal interventions in prodromal AD remains unclear.

Purpose of the Study:

• To assess the feasibility and adherence of an adapted FINGER-based multimodal lifestyle intervention in individuals with prodromal AD.
• To evaluate the intervention with and without the addition of medical food.
• To establish a model for combination therapy trials in early AD.

Main Methods:

• A multinational, proof-of-concept, 6-month randomized controlled trial (RCT) involving 93 participants with prodromal AD.
• Three parallel arms: 1) multimodal lifestyle intervention, 2) multimodal lifestyle intervention plus medical food (Fortasyn Connect), and 3) control group receiving regular health advice.
• Primary outcomes focused on feasibility and adherence; secondary outcomes included adherence to specific domains and lifestyle changes.

Main Results:

• The MIND-ADmini trial successfully enrolled 93 participants and completed the intervention as planned.
• Screening and randomization occurred between September 2017 and May 2019.
• The intervention proceeded according to the trial design, indicating successful implementation.

Conclusions:

• This pilot trial is the first to test the feasibility and adherence of a multimodal lifestyle intervention, with or without medical food, in individuals with prodromal AD.
• The findings suggest this approach is viable and can serve as a foundation for future combination therapy trials.
• It offers a potential model for integrating non-pharmacological, nutritional, and pharmacological interventions for early Alzheimer's disease management.