Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Exercise has the potential to improve cognition, psychological symptoms, physical performance and quality of life, but evidence is scarce. Previous trials are short, often underpowered and involving home based light exercise programs. Most have included nursing homes residents with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise is effective in improving cognition, physical performance and quality of life as well as reducing the prevalence of psychological symptoms among AD patients.
Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90 years with mild to moderate AD. The participants will be randomly allocated into two groups: An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week and a control group only receiving usual care. The hypothesis is that aerobic exercise will improve physical function, the cognitive and daily functioning and quality of life in people with mild to moderate AS.
Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural changes and β-amyloid accumulation.
Further, a health-economic analysis will be performed.
Recruitment was started in January 2012. Last study visits are planned to be performed in January 2014 and results will be available in 2014. This RCT will contribute to evidence regarding the potential effects of a systematic program of physical exercise for patients with Alzheimer's disease.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
16 weeks of aerobic exercise
Aerobic exercise
Physical exercise in the intervention group will be delivered as an individually tailored program consisting of 4 weeks of adaptation exercise followed by 12 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week. The participants can choose from treadmill, stationary bike and crosstrainer.
Control group
Usual care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aerobic exercise
Physical exercise in the intervention group will be delivered as an individually tailored program consisting of 4 weeks of adaptation exercise followed by 12 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week. The participants can choose from treadmill, stationary bike and crosstrainer.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A score of 20 or more on the Mini Mental State Examination (MMSE)
* Imaging (CT or MR of cerebrum) consistent with AD
* Have a caregiver with regular contact to the participant (more than once a month) who is also willing to participate in the study
* In general good health allowing the participant to participate in physical exercise.
* At least 7 years of schooling and Danish speaking
* Visual acuity and hearing must permit neuropsychological testing.
* If the patient is receiving anti-dementia medication or mood stabilizing medication, these must have been given in stable doses for at least 3 months.
Exclusion Criteria
* Any musculoskeletal or joint impairment that could interfere with completion of the study (significant joint problems, back pain or pain in arms and legs that provide problems with mobility in daily activities)
* Male participants with a combination of two or more of the following risk factors even if asymptomatic: smokers, hypertension and hypercholesterolemia
* Severe cerebro vascular disease judged from the CT or MR scans and remarkable hypertension defined as Systolic blood pressure \>180 and diastolic \>100
* Severe psychiatric disease, as well as alcohol or drug abuse within the last 2 years
50 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steen G Hasselbalch
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steen G Hasselbalch, Professor
Role: PRINCIPAL_INVESTIGATOR
Memory Disorders Research Group, Department of Neurology, Copenhagen University Hospital, Rigshospitalet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Danish Dementia Research Centre, Department of Neurology, Rigshospitalet.
Copenhagen, Copenhagen Ø, Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Delgado-Peraza F, Nogueras-Ortiz C, Simonsen AH, Knight DD, Yao PJ, Goetzl EJ, Jensen CS, Hogh P, Gottrup H, Vestergaard K, Hasselbalch SG, Kapogiannis D. Neuron-derived extracellular vesicles in blood reveal effects of exercise in Alzheimer's disease. Alzheimers Res Ther. 2023 Sep 20;15(1):156. doi: 10.1186/s13195-023-01303-9.
Frederiksen KS, Jensen CS, Hogh P, Gergelyffy R, Waldemar G, Andersen BB, Gottrup H, Vestergaard K, Wermuth L, Sondergaard HB, Sellebjerg F, Hasselbalch SG, Simonsen AH. Aerobic exercise does not affect serum neurofilament light in patients with mild Alzheimer's disease. Front Neurosci. 2023 Jan 24;17:1108191. doi: 10.3389/fnins.2023.1108191. eCollection 2023.
Musaeus CS, Johansen LB, Hasselbalch S, Beyer N, Hogh P, Siebner HR, Frederiksen KS. Sixteen Weeks of Aerobic Exercise does not Alter Resting-state Connectivity of the Precuneus in Patients with Alzheimer's Disease. Curr Alzheimer Res. 2022;19(2):171-177. doi: 10.2174/1567205019666220304091241.
Clemmensen FK, Hoffmann K, Siersma V, Sobol N, Beyer N, Andersen BB, Vogel A, Lolk A, Gottrup H, Hogh P, Waldemar G, Hasselbalch SG, Frederiksen KS. The role of physical and cognitive function in performance of activities of daily living in patients with mild-to-moderate Alzheimer's disease - a cross-sectional study. BMC Geriatr. 2020 Nov 27;20(1):513. doi: 10.1186/s12877-020-01926-9.
Frederiksen KS, Larsen CT, Hasselbalch SG, Christensen AN, Hogh P, Wermuth L, Andersen BB, Siebner HR, Garde E. A 16-Week Aerobic Exercise Intervention Does Not Affect Hippocampal Volume and Cortical Thickness in Mild to Moderate Alzheimer's Disease. Front Aging Neurosci. 2018 Sep 25;10:293. doi: 10.3389/fnagi.2018.00293. eCollection 2018.
Sopina E, Sorensen J, Beyer N, Hasselbalch SG, Waldemar G. Cost-effectiveness of a randomised trial of physical activity in Alzheimer's disease: a secondary analysis exploring patient and proxy-reported health-related quality of life measures in Denmark. BMJ Open. 2017 Jun 14;7(6):e015217. doi: 10.1136/bmjopen-2016-015217.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-3-2011-128
Identifier Type: -
Identifier Source: org_study_id