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AzTrials

Alzheimer DiseasePhase 3ADEXNCT01681602

Effect of Physical Exercise in Alzheimer Patients

A Phase 3 study testing Aerobic exercise in people with Alzheimer Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only temporarily slow down progression. Exercise has the potential to improve cognition, psychological symptoms, physical performance and quality of life, but evidence is scarce. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteDenmark
Study dates
Jan 2012to Jun 2014
Phase
Phase 3
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 50 and 90 years
  • 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.

Who cannot join

  • Participation in aerobic exercise (moderate to hard intensity) more than 2 times a week on a regular basis.
  • 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
  • Major neurologic (other than AD), cardiac or other medical diseases that constitutes a contraindication to physical activity. Stent operation or previous myocardial infarction is not an exclusion criteria if the participant has had a recent (within 3 months) normal exercise tests .
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Danish Dementia Research Centre, Department of Neurology, Rigshospitalet.

    Copenhagen, Copenhagen Ø, 2100

Other trials in Denmark

About this study

Official title: Preserving Quality of Life, Physical Health and Functional Ability in Alzheimer's Disease: The Effect of Physical Exercise

Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only temporarily slow down progression.

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.

Read more

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.

Read the detailed description

see protocol article

Being tested
Aerobic exercise
Keywords
Alzheimer Disease, Exercise, Cognition, Quality of life, Cardiovascular fitness, Behavioural or psychological symptoms, Physical fitness
Medical subject headings
Alzheimer Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exerciseOther

    Also called Endurance training

    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.

Study groups in NCT01681602
Study groupRoleWhat they receive
Intervention groupActive comparator16 weeks of aerobic exercise
Receives: Other: Aerobic exercise
Control groupNo interventionUsual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symbol Digit Modalities Test

    Measured: Change in score from baseline to 16 weeks

Secondary outcomes (9)

  1. NPI (psychological symptoms.)

    Measured: Change in score from baseline to 16 weeks

  2. Astrand submaximal bicycle test for estimating VO2 max

    Measured: Change in score from baseline to 16 weeks

  3. Euro-qol-5D-5L (health related quality of life)

    Measured: Change in score from baseline to 16 weeks

  4. Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog).

    Measured: Change in score from baseline to 16 weeks

  5. Changes in physical fitness

    Timed up and go test (TUG), 10 m walk, 10m Dual-Task, 400m fast walking, Sit-to-stand (number in 30 sec.)(STS).

    Measured: Change in score from baseline to 16 weeks

  6. Self-efficacy scale

    Measured: Change in score from baseline to 16 weeks

  7. Verbal fluency

    Measured: Change in score from baseline to 16 weeks

  8. Stroop

    Measured: Change in score from baseline to 16 weeks

  9. MMSE (Mini Mental State Examination)

    Measured: Change in score from baseline to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2014
  4. Study completionJun 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01681602
Sponsor's protocol ID
H-3-2011-128
Acronym
ADEX
Status last verified
Nov 2014
First submitted
30 Apr 2012
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37730689

  • 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.

    PubMed 36761410

  • 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.

    PubMed 35249488

  • 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.

    PubMed 33246408

  • 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.

    PubMed 30319397

  • 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.

    PubMed 28615271

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aerobic exercise in people with Alzheimer Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 6 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: finished, as of the sponsor's last update on 2 Dec 2014. 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 Denmark. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symbol Digit Modalities Test (time frame: Change in score from baseline to 16 weeks). 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 NCT01681602, which also lists 6 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 2 Dec 2014.

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