- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03939286
Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease (DEMENTIA-MOVE)
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
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathrin Reetz, Prof. Dr.
- Phone Number: +49(0)241-80 36516
- Email: kreetz@ukaachen.de
Study Contact Backup
- Name: Alexa Häger, Dr. med.
- Phone Number: +49(0)241-80 37212
- Email: ahaeger@ukaachen.de
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- Recruiting
- RWTH Aachen University Hospital
-
Contact:
- Kathrin Reetz
- Phone Number: +4902418036516 +4902418036516
- Email: kreetz@ukaachen.de
-
Contact:
- Alexa Häger
- Phone Number: +4902418037212 +4902418037212
- Email: ahaeger@ukaachen.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Director: Jörg B. Schulz, Prof. Dr., Clinic for neurology University Hospital Aachen
Publications and helpful links
General Publications
- Beckett MW, Ardern CI, Rotondi MA. A meta-analysis of prospective studies on the role of physical activity and the prevention of Alzheimer's disease in older adults. BMC Geriatr. 2015 Feb 11;15:9. doi: 10.1186/s12877-015-0007-2.
- Bruggemann N, Hagenah J, Reetz K, Schmidt A, Kasten M, Buchmann I, Eckerle S, Bahre M, Munchau A, Djarmati A, van der Vegt J, Siebner H, Binkofski F, Ramirez A, Behrens MI, Klein C. Recessively inherited parkinsonism: effect of ATP13A2 mutations on the clinical and neuroimaging phenotype. Arch Neurol. 2010 Nov;67(11):1357-63. doi: 10.1001/archneurol.2010.281.
- Diehl-Wiesenecker E, von Armin CA, Dupuis L, Muller HP, Ludolph AC, Kassubek J. Adipose Tissue Distribution in Patients with Alzheimer's Disease: A Whole Body MRI Case-Control Study. J Alzheimers Dis. 2015;48(3):825-32. doi: 10.3233/JAD-150426.
- Hilker R, Klein C, Ghaemi M, Kis B, Strotmann T, Ozelius LJ, Lenz O, Vieregge P, Herholz K, Heiss WD, Pramstaller PP. Positron emission tomographic analysis of the nigrostriatal dopaminergic system in familial parkinsonism associated with mutations in the parkin gene. Ann Neurol. 2001 Mar;49(3):367-76.
- Reetz K, Lencer R, Steinlechner S, Gaser C, Hagenah J, Buchel C, Petersen D, Kock N, Djarmati A, Siebner HR, Klein C, Binkofski F. Limbic and frontal cortical degeneration is associated with psychiatric symptoms in PINK1 mutation carriers. Biol Psychiatry. 2008 Aug 1;64(3):241-7. doi: 10.1016/j.biopsych.2007.12.010. Epub 2008 Feb 7.
- Reetz K, Lencer R, Hagenah JM, Gaser C, Tadic V, Walter U, Wolters A, Steinlechner S, Zuhlke C, Brockmann K, Klein C, Rolfs A, Binkofski F. Structural changes associated with progression of motor deficits in spinocerebellar ataxia 17. Cerebellum. 2010 Jun;9(2):210-7. doi: 10.1007/s12311-009-0150-4.
- Raj A, Kuceyeski A, Weiner M. A network diffusion model of disease progression in dementia. Neuron. 2012 Mar 22;73(6):1204-15. doi: 10.1016/j.neuron.2011.12.040. Epub 2012 Mar 21.
- Warren JD, Rohrer JD, Hardy J. Disintegrating brain networks: from syndromes to molecular nexopathies. Neuron. 2012 Mar 22;73(6):1060-2. doi: 10.1016/j.neuron.2012.03.006. Epub 2012 Mar 21.
- Zhou J, Gennatas ED, Kramer JH, Miller BL, Seeley WW. Predicting regional neurodegeneration from the healthy brain functional connectome. Neuron. 2012 Mar 22;73(6):1216-27. doi: 10.1016/j.neuron.2012.03.004. Epub 2012 Mar 21.
- Jucker M, Walker LC. Pathogenic protein seeding in Alzheimer disease and other neurodegenerative disorders. Ann Neurol. 2011 Oct;70(4):532-40. doi: 10.1002/ana.22615.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on Clinical-neurological and neuropsychological tests
-
University Hospital, BonnForschungszentrum Juelich; The Marigold Foundation; Life and Brain Center BonnCompletedMyotonic Dystrophy 1 | Myotonic Dystrophy 2
-
Centre Hospitalier St AnneUnknownPatients With Cognitive DisturbancesFrance
-
Assistance Publique Hopitaux De MarseilleCompleted
-
University Hospital, ToulouseActive, not recruitingCerebral Amyloid AngiopathyFrance
-
University Hospital, GrenobleUnknownAttention Deficit-HyperactivityFrance
-
Istituto Auxologico ItalianoRecruiting
-
University Hospital, AngersCompletedPresymptomatic Huntington DiseaseFrance
-
Hospices Civils de LyonCompleted
-
University Hospital, ToulouseRecruiting
-
Association pour le Développement et l'Organisation...Association Française du Syndrome d'Ondine; Fonds de Recherche en Santé RespiratoireCompletedHealthy | Amyotrophic Lateral Sclerosis | Ondine SyndromeFrance