Back to resultsMultimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease (DEMENTIA-MOVE)
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Clinical-neurological and neuropsychological tests
Blood sampling
Assessment of physical activity via fitness tracker/diary
MRI-examinations
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Disease
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
- 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)
Sites / Locations
- RWTH Aachen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
movement group
control group
Arm Description
intensified training (equipment, coordination, balance)
continuation of physical activity as usual
Outcomes
Primary Outcome Measures
Metabolic changes of the brain induced by intervention program
Sodium MR Imaging
Metabolic changes of the brain induced by intervention program
Phosphor MR Imaging
Structural changes of the brain induced by intervention program
Standard MR Imaging
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03939286
Brief Title
Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease
Acronym
DEMENTIA-MOVE
Official Title
Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In total, about 50 study participants will be examined in a prodromal or symptomatic early stage of Alzheimer's disease. These should be distributed equally randomized into two groups: a movement group (n = 25) with intensified training (equipment, coordination, balance) and a control group with continuation of physical activity as usual and participation in a psychoeducational program (n = 25).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
movement group
Arm Type
Other
Arm Description
intensified training (equipment, coordination, balance)
Arm Title
control group
Arm Type
Other
Arm Description
continuation of physical activity as usual
Intervention Type
Other
Intervention Name(s)
Clinical-neurological and neuropsychological tests
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sampling
Intervention Description
Venous blood sampling (40 ml) is performed according to the usual criteria of sterile working at baseline and after intervention.
Intervention Type
Other
Intervention Name(s)
Assessment of physical activity via fitness tracker/diary
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MRI-examinations
Intervention Description
Standard MRI-methods, Sodium MRI, Phosphor MRS, Wholebody-Fat-MRI
Primary Outcome Measure Information:
Title
Metabolic changes of the brain induced by intervention program
Description
Sodium MR Imaging
Time Frame
T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
Title
Metabolic changes of the brain induced by intervention program
Description
Phosphor MR Imaging
Time Frame
T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
Title
Structural changes of the brain induced by intervention program
Description
Standard MR Imaging
Time Frame
T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrin Reetz, Prof. Dr.
Phone
+49(0)241-80 36516
Email
kreetz@ukaachen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa Häger, Dr. med.
Phone
+49(0)241-80 37212
Email
ahaeger@ukaachen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg B. Schulz, Prof. Dr.
Organizational Affiliation
Clinic for neurology University Hospital Aachen
Official's Role
Study Director
Facility Information:
Facility Name
RWTH Aachen University Hospital
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathrin Reetz
Phone
+4902418036516
Ext
+4902418036516
Email
kreetz@ukaachen.de
First Name & Middle Initial & Last Name & Degree
Alexa Häger
Phone
+4902418037212
Ext
+4902418037212
Email
ahaeger@ukaachen.de
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25887627
Citation
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.
Results Reference
background
PubMed Identifier
21060012
Citation
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.
Results Reference
background
PubMed Identifier
26402111
Citation
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.
Results Reference
background
PubMed Identifier
11261512
Citation
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.
Results Reference
background
PubMed Identifier
18261714
Citation
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.
Results Reference
background
PubMed Identifier
20016963
Citation
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.
Results Reference
background
PubMed Identifier
22445347
Citation
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.
Results Reference
background
PubMed Identifier
22445334
Citation
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.
Results Reference
background
PubMed Identifier
22445348
Citation
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.
Results Reference
background
PubMed Identifier
22028219
Citation
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.
Results Reference
background
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Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease
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