Alzheimer's DiseaseNCT01021644
Genes, Exercise, Memory and Neurodegeneration
A study testing aerobic exercise-training and stretch exercise in people with Alzheimer's Disease, run by Howard University at 2 sites in United States.
Trial summary
The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- aerobic exercise-training and stretch exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Dec 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 60 years
- Ability to exercise vigorously without harm
- Mild AD
- Study partner
- In good general health
- Willing to exercise for 6 months
- Body Mass Index (BMI) less than 37
- Women participants must be postmenopausal for at least 2 years, and maintain current hormone replacement therapy status and allowed medication usage for the duration of the study
Who cannot join
- MMSE score below 20
- TG (Triglyceride) greater than 400 mg/dl
- LDL-C levels greater than 95% or HDL-C levels less than 10% of age and sex-adjusted norms
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple University Exercise Physiology Laboratory
Philadelphia, Pennsylvania, 19140
Howard University General Clinical Research Center (GCRC)
Washington D.C., District of Columbia, 20060
About this study
Official title: Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration
The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study.
Read the detailed description
This study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. It is yet to be determined whether African Americans with mild AD can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. In addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of APOE to aerobic fitness-induced changes in neurocognition. The long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (HDL-C), elevated inflammation (C-reactive protein (CRP) and interleukins (IL-1A)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase AD risk. Because many of these putative AD risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in AD risk.
- Conditions
- Alzheimer's Disease
- Being tested
- aerobic exercise-training, stretch exercise
- Keywords
- APOE, Apolipoprotein E, Cognition Disorders, Neurocognition
- Medical subject headings
- Alzheimer Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise-trainingBehavioural
3 times per week for 6 months
stretch exerciseBehavioural
3 times per week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise-training | Experimental | Not described Receives: Behavioral: aerobic exercise-training |
| stretch exercise | Active comparator | Not described Receives: Behavioral: stretch exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
AD Assessment Scale-Cognitive (ADAS-COG)
Measured: baseline, 3 and 6 months
Secondary outcomes (9)
Mini-Mental State Exam (MMSE)
Measured: baseline, 3 and 6 months
CDR (Clinical Dementia Rating) Scale
Measured: baseline, 3 and 6 months
Logical Memory Test (Delayed Paragraph Recall)
Measured: baseline and 6 months
Visuospatial and Visuographic: Clock Drawing Test
Measured: baseline and 6 months
American National Adult Reading Test (ANART)
Measured: baseline and 6 months
Neuropsychiatric Inventory Q (NPIQ)
Measured: baseline and 6 months
Geriatric Depression Scale
Measured: baseline and 6 months
Activities of Daily Living (ADCS-ADL)
Measured: baseline and 6 months
PET imaging to measure cerebral glucose homeostasis/metabolism
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Obisesan, Howard University
- Investigators
- Thomas O. Obisesan, MD, MPH, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021644
- Sponsor's protocol ID
- IA0172
- Other IDs
- 1R01AG031517-01A209, 1R01AG031517-01
- Status last verified
- Feb 2014
- First submitted
- 25 Nov 2009
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.
PubMed 18768414Barnes LL, Wilson RS, Li Y, Gilley DW, Bennett DA, Evans DA. Change in cognitive function in Alzheimer's disease in African-American and white persons. Neuroepidemiology. 2006;26(1):16-22. doi: 10.1159/000089231. Epub 2005 Oct 25.
PubMed 16254449Wilkins CH, Grant EA, Schmitt SE, McKeel DW, Morris JC. The neuropathology of Alzheimer disease in African American and white individuals. Arch Neurol. 2006 Jan;63(1):87-90. doi: 10.1001/archneur.63.1.87.
PubMed 16401740Larson EB, Wang L, Bowen JD, McCormick WC, Teri L, Crane P, Kukull W. Exercise is associated with reduced risk for incident dementia among persons 65 years of age and older. Ann Intern Med. 2006 Jan 17;144(2):73-81. doi: 10.7326/0003-4819-144-2-200601170-00004.
PubMed 16418406Kramer AF, Erickson KI, Colcombe SJ. Exercise, cognition, and the aging brain. J Appl Physiol (1985). 2006 Oct;101(4):1237-42. doi: 10.1152/japplphysiol.00500.2006. Epub 2006 Jun 15.
PubMed 16778001
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration
- ClinicalTrials.gov ID
- NCT01021644
- Acronym / sponsor ID
- IA0172
- Conditions
- Alzheimer's Disease
- Keywords
- APOE, Apolipoprotein E, Cognition Disorders, Neurocognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Nov 2009 (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 primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study.
Detailed description
This study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. It is yet to be determined whether African Americans with mild AD can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. In addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of APOE to aerobic fitness-induced changes in neurocognition. The long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (HDL-C), elevated inflammation (C-reactive protein (CRP) and interleukins (IL-1A)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase AD risk. Because many of these putative AD risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in AD risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise-training | Experimental | Behavioral: aerobic exercise-training |
| stretch exercise | Active comparator | Behavioral: stretch exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age over 60 years
- Ability to exercise vigorously without harm
- Mild AD
- Study partner
- In good general health
Key exclusion criteria (3 listed)
- MMSE score below 20
- TG (Triglyceride) greater than 400 mg/dl
- LDL-C levels greater than 95% or HDL-C levels less than 10% of age and sex-adjusted norms
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 |
|---|---|---|
| aerobic exercise-training3 times per week for 6 months | Behavioural | aerobic exercise-training |
| stretch exercise3 times per week for 6 months | Behavioural | stretch exercise |
Primary outcome
AD Assessment Scale-Cognitive (ADAS-COG)
Time frame: baseline, 3 and 6 months
9 secondary outcomes
Mini-Mental State Exam (MMSE)
Time frame: baseline, 3 and 6 months
CDR (Clinical Dementia Rating) Scale
Time frame: baseline, 3 and 6 months
Logical Memory Test (Delayed Paragraph Recall)
Time frame: baseline and 6 months
Visuospatial and Visuographic: Clock Drawing Test
Time frame: baseline and 6 months
American National Adult Reading Test (ANART)
Time frame: baseline and 6 months
Neuropsychiatric Inventory Q (NPIQ)
Time frame: baseline and 6 months
Geriatric Depression Scale
Time frame: baseline and 6 months
Activities of Daily Living (ADCS-ADL)
Time frame: baseline and 6 months
PET imaging to measure cerebral glucose homeostasis/metabolism
Time frame: baseline and 6 months
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 14 Feb 2014.
- Background: PubMed 18768414Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.
- Background: PubMed 16254449Barnes LL, Wilson RS, Li Y, Gilley DW, Bennett DA, Evans DA. Change in cognitive function in Alzheimer's disease in African-American and white persons. Neuroepidemiology. 2006;26(1):16-22. doi: 10.1159/000089231. Epub 2005 Oct 25.
- Background: PubMed 16401740Wilkins CH, Grant EA, Schmitt SE, McKeel DW, Morris JC. The neuropathology of Alzheimer disease in African American and white individuals. Arch Neurol. 2006 Jan;63(1):87-90. doi: 10.1001/archneur.63.1.87.
- Background: PubMed 16418406Larson EB, Wang L, Bowen JD, McCormick WC, Teri L, Crane P, Kukull W. Exercise is associated with reduced risk for incident dementia among persons 65 years of age and older. Ann Intern Med. 2006 Jan 17;144(2):73-81. doi: 10.7326/0003-4819-144-2-200601170-00004.
- Background: PubMed 16778001Kramer AF, Erickson KI, Colcombe SJ. Exercise, cognition, and the aging brain. J Appl Physiol (1985). 2006 Oct;101(4):1237-42. doi: 10.1152/japplphysiol.00500.2006. Epub 2006 Jun 15.
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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.
Thomas O. Obisesan, MD, MPH principal investigator
Howard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise-training and stretch exercise in people with Alzheimer's Disease, run by Howard University at 2 sites 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 8 inclusion and 3 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
AD Assessment Scale-Cognitive (ADAS-COG) (time frame: baseline, 3 and 6 months). 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 NCT01021644, which also lists 5 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 14 Feb 2014; AzTrials last refreshed its copy on 27 Oct 2026.