Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity

Summary

α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.

The aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year.

Eighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the "Deutsches Zentrum für Neurodegenerative Erkrankungen" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https://clinicaltrials.gov/study/NCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.

Conditions

• Parkinson Disease
• Prodromal Stage
• Neurodegenerative Diseases
• Basal Ganglia Diseases
• Central Nervous System Diseases
• Synucleinopathies
• Nervous System Diseases
• Cerebral Disorder
• Brain Diseases
• Parkinsonian Disorders

Interventions

BEHAVIORAL

Increase of physical activity volume and intensity with the use of a motivational smartphone application

A motivational smartphone application will be available for all participants using their own smartphone: the Alpha-Fit app, comparable to the SLOW-SPEED app (https://clinicaltrials.gov/study/NCT06993142). The Alpha-Fit app will motivate participants to increase the volume and intensity of their physical activity in daily life over a long period of time (12 months) based on their own baseline levels. Different treatment arms will receive different physical activity goals. The app offers participants feedback and support, that will stimulate them to reach their individual physical activity goal (i.e. incremental relative increase of step count and minutes exerting ≥ 64% of maximum heart rate reflecting moderate-to-vigorous physical activity (MVPA) relative to baseline level).

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• IJsfontein B.V., Netherlands

  collaborator UNKNOWN

• Synaptikon GmbH

  collaborator UNKNOWN

• Parkinson Stiftung

  collaborator UNKNOWN

• University Hospital, Bonn

  lead OTHER

Principal Investigators

• Michael B Sommerauer, Dr. · University Hospital of Bonn

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-04

Primary Completion

2028-12-01

Completion

2029-12-01

Countries

• Germany

Study Locations