RecruitingNot ApplicableNCT07324330

Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity

Sponsor

University Hospital, Bonn

Enrollment

130 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether increasing daily physical activity (using a smartphone app and activity tracker) can slow cognitive decline in people at risk for Parkinson's disease — specifically those who have a sleep condition called isolated REM sleep behavior disorder (iRBD), which is a known early sign of Parkinson's. **You may be eligible if...** - You are 50–80 years old - You have been diagnosed with iRBD confirmed by a sleep study (for the patient group), OR you are a healthy volunteer aged 50–80 (for the comparison group) - You currently do less than 10,000 steps per day - You speak German at a native or near-native level (C1/C2) - You own a compatible smartphone (Android 9+ or iOS 15+, screen at least 4.6 inches) **You may NOT be eligible if...** - You have significant heart disease - You have cognitive or dexterity problems that prevent smartphone use - You own a Huawei P8 Lite, P9 Lite, Xiaomi Mi 6, or Huawei P20 Lite (incompatible with the fitness tracker) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIncrease 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).