Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease (DEMENTIA-MOVE)

May 6, 2019 updated by: RWTH Aachen University

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kathrin Reetz, Prof. Dr.
  • Phone Number: +49(0)241-80 36516
  • Email: kreetz@ukaachen.de

Study Contact Backup

Study Locations

    • NRW
      • Aachen, NRW, Germany, 52074
        • Recruiting
        • RWTH Aachen University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Severe systemic disease, which is expected to worsen during exercise
  • Difficult to adjust diabetes mellitus II
  • Difficult to set art. Hypertension in the last 6 months
  • Severe psychiatric illness
  • Severe orthopedic disease
  • Alcohol and / or drug abuse in the last 2 years
  • Chronic pain and / or musculoskeletal disease, which prevent regular physical activity
  • Acute fracture or orthopedic injury last month
  • cancer in the last 5 years (except basal cell and spinal cell carcinoma) Contraindications for MRI examination below 3 Tesla (for example, implantation of ferromagnetic parts) For study participants, the following measures must be observed due to the direct effects of the magnetic field, in particular the force exerted on para- or ferromagnetic bodies: Study participants with incorporated metallic implants are not admitted. Pregnancy or lactation, traumatic brain injury, neurological or psychiatric disorders (other than the neurological disease to be studied for patients), relevant and severe other medical conditions, e.g. metabolic, endocrinological or cardiac disorders, mental retardation, magnetic metal implants (also intrauterine spiral).

Furthermore, the spatial conditions in the magnet do not allow to examine persons with certain back complaints or a strong overweight. As a rule, a body mass index (BMI, weight [kg] / size2 [cm2]) of > 30 is the exclusion criterion. With regard to the participation in the exercise in advance with unclear suitability is a consultation with the attending family doctor regarding possible contraindications, which are a regular participation in a sports program in the way.

Specifically, as exclusion criteria count:

Diseases:

  • epilepsy
  • severe cardiac pre-existing conditions
  • Musculoskeletal disorders that are contrary to regular exercise
  • advanced osteoporosis
  • Increased fall risk / imbalance
  • Advanced Heart Failure, Shortness of Breath, Severe Pulmonary Disease, which are contrary to regular physical activity
  • Diabetes mellitus prone to hypoglycaemia and hyperglycemia

Conditions:

  • pregnancy
  • Uncertain knowledge about possibly existing pregnancy

Contraceptives:

  • Any type of intrauterine device
  • Spiral made of copper Metal-containing implants or devices in / on the body (all non-metal implants / devices / patches will undergo a thorough examination based on the MRI Safety

Listing www.mrisafety.com):

  • Pacemaker / implanted pacemaker wires
  • Implanted defibrillator
  • Drug pump / infusion device
  • Stimulation device / electrodes

Non-MRI-compatible implants, for example, surgical screws, plates, nails, etc:

  • vascular / lumen filters, wire rings, wire spirals, stents, vascular clips
  • Artificial heart valve
  • Transdermal patches
  • epithesis (or partial epithesis)
  • shunts, catheters, wire sutures

Metal in / on the body:

  • Splinter / gunshot wounds
  • Metal shards in the eye, even if everything was supposedly removed
  • Piercing

Dental metals:

  • Any type of implant in the jawbone area / dental implant older than 20 years
  • No contraindications: Amalgam fillings, inlays, crowns, single crowned teeth as a denture base for a denture termed a telescopic denture, firmly screwed dentures

Additional:

  • cochlear implant
  • Ventilation Tubes
  • tattoos / permanent make-up (only after the most exact examination and special approval see separate explanation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: movement group
intensified training (equipment, coordination, balance)
The tests include established standardized questionnaires and detailed clinical neuropsychological examinations (e.g., tests on cognition and perception). In order to avoid exercise effects in multiple examinations, so-called parallel procedures should be used.
Venous blood sampling (40 ml) is performed according to the usual criteria of sterile working at baseline and after intervention.
All study participants, regardless of group classification, are randomly selected for a period of one week using Fitbit Charge 2® fitness trackers. The study participants are asked in this context to pursue their regular activity and to wear the bracelets for a week throughout. All study participants are asked to document their activities in a hand-written diary.
Standard MRI-methods, Sodium MRI, Phosphor MRS, Wholebody-Fat-MRI
Other: control group
continuation of physical activity as usual
The tests include established standardized questionnaires and detailed clinical neuropsychological examinations (e.g., tests on cognition and perception). In order to avoid exercise effects in multiple examinations, so-called parallel procedures should be used.
Venous blood sampling (40 ml) is performed according to the usual criteria of sterile working at baseline and after intervention.
All study participants, regardless of group classification, are randomly selected for a period of one week using Fitbit Charge 2® fitness trackers. The study participants are asked in this context to pursue their regular activity and to wear the bracelets for a week throughout. All study participants are asked to document their activities in a hand-written diary.
Standard MRI-methods, Sodium MRI, Phosphor MRS, Wholebody-Fat-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic changes of the brain induced by intervention program
Time Frame: T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
Sodium MR Imaging
T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
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
T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
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
T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jörg B. Schulz, Prof. Dr., Clinic for neurology University Hospital Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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