Alzheimer DiseaseDEMENTIA-MOVENCT03939286
Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease
A study testing Clinical-neurological and neuropsychological tests, Blood sampling and Assessment of physical activity via fitness tracker/diary in people with Alzheimer Disease, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Clinical-neurological and neuropsychological tests, Blood sampling and Assessment of physical activity via fitness tracker/diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2019to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 48Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
Kathrin Reetz, +4902418036516 ext. +4902418036516, kreetz@ukaachen.de
Alexa Häger, +4902418037212 ext. +4902418037212, ahaeger@ukaachen.de
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Clinical-neurological and neuropsychological tests, Blood sampling, Assessment of physical activity via fitness tracker/diary, MRI-examinations
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical-neurological and neuropsychological testsOther
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.
Blood samplingDiagnostic test
Venous blood sampling (40 ml) is performed according to the usual criteria of sterile working at baseline and after intervention.
Assessment of physical activity via fitness tracker/diaryOther
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.
MRI-examinationsOther
Standard MRI-methods, Sodium MRI, Phosphor MRS, Wholebody-Fat-MRI
| Study group | Role | What they receive |
|---|---|---|
| movement group | Other | intensified training (equipment, coordination, balance) Receives: Other: Clinical-neurological and neuropsychological tests; Diagnostic Test: Blood sampling; Other: Assessment of physical activity via fitness tracker/diary; Other: MRI-examinations |
| control group | Other | continuation of physical activity as usual Receives: Other: Clinical-neurological and neuropsychological tests; Diagnostic Test: Blood sampling; Other: Assessment of physical activity via fitness tracker/diary; Other: MRI-examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic changes of the brain induced by intervention program
Sodium MR Imaging
Measured: T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
Metabolic changes of the brain induced by intervention program
Phosphor MR Imaging
Measured: T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
Structural changes of the brain induced by intervention program
Standard MR Imaging
Measured: T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start8 Apr 2019
- Primary completionApr 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörg B. Schulz, Prof. Dr., Study director, Clinic for neurology University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939286
- Sponsor's protocol ID
- 19-064
- Acronym
- DEMENTIA-MOVE
- Status last verified
- May 2019
- First submitted
- 5 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25887627Bruggemann 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.
PubMed 21060012Diehl-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.
PubMed 26402111Hilker 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.
PubMed 11261512Reetz 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.
PubMed 18261714Reetz 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.
PubMed 20016963Raj 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.
PubMed 22445347Warren 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.
PubMed 22445334Zhou 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.
PubMed 22445348Jucker 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.
PubMed 22028219
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging Study on Physical Activity in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03939286
- Acronym / sponsor ID
- DEMENTIA-MOVE / 19-064
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| movement group | Other | Other: Clinical-neurological and neuropsychological tests, Diagnostic Test: Blood sampling, Other: Assessment of physical activity via fitness tracker/diary, Other: MRI-examinationsintensified training (equipment, coordination, balance) |
| control group | Other | Other: Clinical-neurological and neuropsychological tests, Diagnostic Test: Blood sampling, Other: Assessment of physical activity via fitness tracker/diary, Other: MRI-examinationscontinuation of physical activity as usual |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (48 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical-neurological and neuropsychological testsThe 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. | Other | control group, movement group |
| Blood samplingVenous blood sampling (40 ml) is performed according to the usual criteria of sterile working at baseline and after intervention. | Diagnostic test | control group, movement group |
| Assessment of physical activity via fitness tracker/diaryAll 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. | Other | control group, movement group |
| MRI-examinationsStandard MRI-methods, Sodium MRI, Phosphor MRS, Wholebody-Fat-MRI | Other | control group, movement group |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 25887627Beckett 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.
- Background: PubMed 21060012Bruggemann 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.
- Background: PubMed 26402111Diehl-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.
- Background: PubMed 11261512Hilker 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.
- Background: PubMed 18261714Reetz 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.
- Background: PubMed 20016963Reetz 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.
- Background: PubMed 22445347Raj 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.
- Background: PubMed 22445334Warren 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.
- Background: PubMed 22445348Zhou 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.
- Background: PubMed 22028219Jucker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg B. Schulz, Prof. Dr. study director
Clinic for neurology University Hospital Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical-neurological and neuropsychological tests, Blood sampling and Assessment of physical activity via fitness tracker/diary in people with Alzheimer Disease, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathrin Reetz, Prof. Dr. (+49(0)241-80 36516, kreetz@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic changes of the brain induced by intervention program (time frame: T1 (baseline), T3 (6 months, after intervention), T4 (optional, 1 year after intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03939286, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.