Skip to main content
Clinical Trials/NCT03939286
NCT03939286
Unknown
Not Applicable

Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease

RWTH Aachen University1 site in 1 country50 target enrollmentApril 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
RWTH Aachen University
Enrollment
50
Locations
1
Primary Endpoint
Structural changes of the brain induced by intervention program
Last Updated
6 years ago

Overview

Brief Summary

This study aims to gain a better understanding of metabolic early changes in neurodegenerative diseases, in order to enable new diagnostic and therapeutic approaches in the future. Further, it aims to identify specific movement-induced changes at the cerebral level, on cognition, on quality of life and physical fitness, and on serology parameters in neurodegenerative diseases.

In general, valid biomarkers are needed for early diagnosis and prediction of disease progression. It has been hypothesized that metabolic changes may precede structural changes and may be examined by intervention with exercise therapy. The non-invasive, in vivo characterization and diagnosis of such metabolic changes is therefore of paramount importance. In this line, this research project is focused on applying magnetic resonance imaging (MRI) based metabolic imaging techniques such as sodium MRI and phosphorus magnetic resonance spectroscopy (MRS) with standard structural and functional MRI methods, combined with exercise training, in order to detect biomarkers early in different stages of neurodegenerative diseases. Moreover, this project aims to examine the sensitivity of metabolic imaging with sodium and phosphorus sequences over classical MRI imaging with whole body fat sequences, in order to detect cerebral alterations.

At the end, the medical benefit of the planned project lies in the fact that the expected findings are groundbreaking for the understanding of the phenomenology and pathobiology of neurodegenerative diseases. This is the basis for the development of new methods for early diagnosis and individualized medicine with the optimization of future treatment options.

Registry
clinicaltrials.gov
Start Date
April 8, 2019
End Date
October 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • prodromal or early symptomatic Alzheimer's disease according to the S3 guidelines of the German Society of Neurology in relation to the IWG-2 criteria for the definition of probable Alzheimer's disease
  • Age between 50 and 80 years
  • Mini Mental State Examination (MMSE)\> 19 (screening at least 12 weeks before baseline visit)
  • Cognitive ability to understand the task as well as regular participation in exercise program, based on assessment of the treating neurologist and / or neuropsychologist
  • For antidementive or antidepressant medication, stable medication for at least 30 days
  • No visual or auditory limitation preventing participation in cognitive and functional testing
  • Interested in regular participation for 6 months, doing domestic exercises
  • Presence of a written informed consent
  • Exclusion criteria:
  • Heart attack or evidence of coronary heart disease (angina) in the last 2 years

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Structural changes of the brain induced by intervention program

Time Frame: T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)

Standard MR Imaging

Metabolic changes of the brain induced by intervention program

Time Frame: T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)

Phosphor MR Imaging

Study Sites (1)

Loading locations...

Similar Trials