Alzheimer's DiseaseNCT00267124
Brain Aging Project--Kansas University
An observational study of Alzheimer's Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of exercise and cardiorespiratory fitness on age-related brain changes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Aug 2009
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: KU memory clinic patients, volunteers from the community, and the states of Kansas and Missouri
Who may be able to join
- Age 65 years or older
- Healthy male or female
- Normal control volunteers and early Alzheimer's disease patients
- Clinical Dementia Rating of 0, 0.5, or 1.0
- On stable doses of medications
Who cannot join
- Unstable angina
- Schizophrenia
- Clinical signs of depression; major depression; mental health disorder; nervous system disorder
- Significant visual/auditory impairment
- Significant system illness; cancer
- Pacemaker/metal
Show all 12Show fewer
- Thyroid problems
- Kidney dialysis
- Organ transplant
- Alcoholism
- Heart surgery
- Insulin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: KU Brain Aging Project
The purpose of this study is to determine the effects of exercise and cardiorespiratory fitness on age-related brain changes.
Read the detailed description
The mission of the KU Brain Aging Project is to promote healthy brain aging. How the brain changes with age is not well-characterized and even less is known about the factors influencing the rate of brain aging. Thus, we are using MRI scans to examine the structure of the brain in relation to important lifestyle factors. This will allow us to better understand the processes influencing the brain as it ages. In turn, this will help identify specific ways to promote healthy brain aging and, perhaps, prevent the onset of Alzheimer's disease.
Participants complete 4 visits over several months. The first visit entails a clinical evaluation and memory testing involving the use of paper and pencil testing. The second visit is an MRI brain scan which lasts approximately one hour. The third visit involves drawing blood for laboratory testing and blood banking for future lab studies, lasting roughly 4 hours. The glucose tolerance test is administered. The fourth and final visit is an assessment of the participant's metabolism and exercise testing. This visit lasts approximately two hours.
- Conditions
- Alzheimer's Disease
- Keywords
- cognitive decline, dementia, neuroimaging
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | elderly people who have normal cognition | |
| 2 | elderly people who have mild to moderate Alzheimer's disease |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startNov 2004
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Burns, MD, Principal investigator, University of Kansas Medical Center, Landon Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267124
- Sponsor's protocol ID
- IA0089
- Other IDs
- 1R03AG026374-01
- Status last verified
- Apr 2017
- First submitted
- 16 Dec 2005
- Last updated
- 6 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KU Brain Aging Project
- ClinicalTrials.gov ID
- NCT00267124
- Acronym / sponsor ID
- IA0089
- Conditions
- Alzheimer's Disease
- Keywords
- cognitive decline, dementia, neuroimaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Kansas, National Institute on Aging (NIA)
- Study start
- Nov 2004 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Dec 2005 (estimated)
- 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.
The purpose of this study is to determine the effects of exercise and cardiorespiratory fitness on age-related brain changes.
Detailed description
The mission of the KU Brain Aging Project is to promote healthy brain aging. How the brain changes with age is not well-characterized and even less is known about the factors influencing the rate of brain aging. Thus, we are using MRI scans to examine the structure of the brain in relation to important lifestyle factors. This will allow us to better understand the processes influencing the brain as it ages. In turn, this will help identify specific ways to promote healthy brain aging and, perhaps, prevent the onset of Alzheimer's disease.
Participants complete 4 visits over several months. The first visit entails a clinical evaluation and memory testing involving the use of paper and pencil testing. The second visit is an MRI brain scan which lasts approximately one hour. The third visit involves drawing blood for laboratory testing and blood banking for future lab studies, lasting roughly 4 hours. The glucose tolerance test is administered. The fourth and final visit is an assessment of the participant's metabolism and exercise testing. This visit lasts approximately two hours.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –elderly people who have normal cognition |
| 2 | – | –elderly people who have mild to moderate Alzheimer's disease |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- KU memory clinic patients, volunteers from the community, and the states of Kansas and Missouri
Key inclusion criteria (5 listed)
- Age 65 years or older
- Healthy male or female
- Normal control volunteers and early Alzheimer's disease patients
- Clinical Dementia Rating of 0, 0.5, or 1.0
- On stable doses of medications
Key exclusion criteria (12 listed)
- Unstable angina
- Schizophrenia
- Clinical signs of depression; major depression; mental health disorder; nervous system disorder
- Significant visual/auditory impairment
- Significant system illness; cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- KU Brain Imaging ProjectLink provided by the sponsor.
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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.
Jeffrey Burns, MD principal investigator
University of Kansas Medical Center, Landon Center on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by University of Kansas Medical Center at 1 site in United States.
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 5 inclusion and 12 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 6 Apr 2017. 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 United States. 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?
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.
Where can I read the original study information?
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 6 Apr 2017.