Ongoing Studies Closed to Enrollment

The Brain Aging Project

Goal: To examine how structural MRI brain changes relate to various lifestyle factors, including fitness and physical activity, in normal aging and Alzheimer's disease.
Participants: 165 adults 60+ with early-stage Alzheimer's disease and those with little to no memory problems.
Duration: 2 years
Investigator/Sponsor: Jeffrey Burns, M.D., MS (PI). Funded in part by grants from the National Institutes of Health and by generous donations to the KU Endowment Association.
Results: Analyses are ongoing but results have demonstrated a positive association between cardiorespiratory health (i.e. heart, lung and muscle fitness) and brain structure in those in the earliest stages of AD. Additionally, Alzheimer's is associated with changes throughout the body, including changes in muscle mass, bone density and body mass index.
Publications:

1: Vidoni ED, Honea RA, Billinger SA, Swerdlow RH, Burns JM. Cardiorespiratory fitness is associated with atrophy in Alzheimer's and aging over 2 years. Neurobiol Aging. 2012 Aug;33(8):1624-32. Epub 2011 May 4. PubMed PMID: 21531480; PubMed Central PMCID: PMC3156963.

2: Royall DR, Palmer RF, Vidoni ED, Honea RA, Burns JM. The Default Mode Network and Related Right Hemisphere Structures may be the Key Substrates of Dementia. J Alzheimers Dis. 2012 Jul 27. [Epub ahead of print] PubMed PMID: 22842866.

3: Vidoni ED, Billinger SA, Lee C, Hamilton J, Burns JM. The physical performance test predicts aerobic capacity sufficient for independence in early-stage Alzheimer disease. J Geriatr Phys Ther. 2012 Apr-Jun;35(2):72-8. PubMed PMID: 22020383; PubMed Central PMCID: PMC3266977.

4: Burns JM, Honea RA, Vidoni ED, Hutfles LJ, Brooks WM, Swerdlow RH. Insulin is differentially related to cognitive decline and atrophy in Alzheimer's disease and aging. Biochim Biophys Acta. 2012 Mar;1822(3):333-9. Epub 2011 Jul 1. PubMed PMID: 21745566; PubMed Central PMCID: PMC3264795.

5: Billinger SA, Vidoni ED, Honea RA, Burns JM. Cardiorespiratory response to exercise testing in individuals with Alzheimer's disease. Arch Phys Med Rehabil. 2011 Dec;92(12):2000-5. PubMed PMID: 22133248; PubMed Central PMCID: PMC3229718.

6: Vidoni ED, Townley RA, Honea RA, Burns JM; Alzheimer's Disease Neuroimaging Initiative. Alzheimer disease biomarkers are associated with body mass index. Neurology. 2011 Nov 22;77(21):1913-20. PubMed PMID: 22105948; PubMed Central PMCID: PMC3233188.

7: Anderson HS, Kluding PM, Gajewski BJ, Donnelly JE, Burns JM. Reliability of peak treadmill exercise tests in mild Alzheimer disease. Int J Neurosci. 2011 Aug;121(8):450-6. Epub 2011 May 17. PubMed PMID: 21574893; PubMed Central PMCID: PMC3143203.

8: Wetmore JB, Honea RA, Vidoni ED, Almehmi A, Burns JM. Role of lean body mass in estimating glomerular filtration rate in Alzheimer disease. Nephrol Dial Transplant. 2011 Jul;26(7):2222-31. Epub 2010 Nov 23. PubMed PMID: 21098656; PubMed Central PMCID: PMC3145378.

9: Honea RA, Swerdlow RH, Vidoni ED, Burns JM. Progressive regional atrophy in normal adults with a maternal history of Alzheimer disease. Neurology. 2011 Mar 1;76(9):822-9. PubMed PMID: 21357834; PubMed Central PMCID: PMC3053329.

10: Cronk BB, Johnson DK, Burns JM; Alzheimer's Disease Neuroimaging Initiative. Body mass index and cognitive decline in mild cognitive impairment. Alzheimer Dis Assoc Disord. 2010 Apr-Jun;24(2):126-30. PubMed PMID: 19571736; PubMed Central PMCID: PMC3068614.

11: Burns JM, Johnson DK, Watts A, Swerdlow RH, Brooks WM. Reduced lean mass in early Alzheimer disease and its association with brain atrophy. Arch Neurol. 2010 Apr;67(4):428-33. PubMed PMID: 20385908; PubMed Central PMCID: PMC2855150.

12: Honea RA, Swerdlow RH, Vidoni ED, Goodwin J, Burns JM. Reduced gray matter volume in normal adults with a maternal family history of Alzheimer disease. Neurology. 2010 Jan 12;74(2):113-20. PubMed PMID: 20065246; PubMed Central PMCID: PMC2809030.

13: Honea RA, Thomas GP, Harsha A, Anderson HS, Donnelly JE, Brooks WM, Burns JM. Cardiorespiratory fitness and preserved medial temporal lobe volume in Alzheimer disease. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):188-97. PubMed PMID: 19812458; PubMed Central PMCID: PMC2760037.

14: Loskutova N, Honea RA, Vidoni ED, Brooks WM, Burns JM. Bone density and brain atrophy in early Alzheimer's disease. J Alzheimers Dis. 2009;18(4):777-85. PubMed PMID: 19661621; PubMed Central PMCID: PMC2842449.

15: Honea RA, Vidoni E, Harsha A, Burns JM. Impact of APOE on the healthy aging brain: a voxel-based MRI and DTI study. J Alzheimers Dis. 2009;18(3):553-64. PubMed PMID: 19584447; PubMed Central PMCID: PMC2892293.

16: Burns JM, Cronk BB, Anderson HS, Donnelly JE, Thomas GP, Harsha A, Brooks WM, Swerdlow RH. Cardiorespiratory fitness and brain atrophy in early Alzheimer disease. Neurology. 2008 Jul 15;71(3):210-6. PubMed PMID: 18625967; PubMed Central PMCID: PMC2657657.

17: Burns JM, Mayo MS, Anderson HS, Smith HJ, Donnelly JE. Cardiorespiratory fitness in early-stage Alzheimer disease. Alzheimer Dis Assoc Disord. 2008 Jan-Mar;22(1):39-46. PubMed PMID: 18317245.


DHA Neuroprotective Study

Goal: Evaluate the ability of docosahexaenoic acid (omega-3 fatty acid contained in fish oil) to slow the progression of Alzheimer's disease. 
Participants: Ten adults age 50+ with mild to moderate Alzheimer's disease who are not currently on omega-3 fish oil supplements. This is an add-on therapy to the participant's current medications.
Duration: 18 months.
Investigator/Sponsor: Jeffrey Burns, M.D., MS, (Site PI). National Institute on Aging (NIA) and the Alzheimer's Disease Cooperative Study Group
Results: Supplementation with DHA compared with placebo did not slow the rate of cognitive and functional decline in patients with mild to moderate Alzheimer disease. More information may be available at ClinicalTrials.gov
Publications:

Quinn JF, Raman R, Thomas RG, Yurko-Mauro K, Nelson EB, Van Dyck C, Galvin JE, Emond J, Jack CR Jr, Weiner M, Shinto L, Aisen PS. Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial. JAMA. 2010 Nov 3;304(17):1903-11. PubMed PMID: 21045096; PubMed Central PMCID: PMC3259852.


Valproate in Dementia (VALID) Study

Goal: To determine if valproate delays the onset of behavioral problems and Alzheimer's disease progression. 
Participants: 15 adults age 55+ with mild to moderate Alzheimer's disease and no evidence of agitation or psychotic behaviors.
Duration: Two years
Investigator/Sponsor: Jeffrey Burns, M.D., MS (Site PI). National Institute on Aging (NIA) and Alzheimer's Disease Cooperative Study group.
Results: Valproate did not significantly reduce agitation or improve cognition compared to a placebo. More information may be available at ClinicalTrials.gov 


Self-Care TALK to Promote AD Spousal Caregiver Health

Goal: Examine the benefits of a health program to promote caregiver health
Participants: 46 caregivers age 60+ currently living with an individual diagnosed with Alzheimer's disease
Duration: Three visits
Investigator/Sponsor: Dr. Cindy Teel, RN, Ph.D. (PI). National Institute of Nursing Research
Results: Not yet available.


Elan 301

Goal: The study investigated a drug called Bapineuzimab, a therapy aimed at slowing Alzheimer's disease progression with an infusion of antibodies that target the amyloid protein, which accumulates in the brain of individuals with Alzheimer's disease. This study targeted people who did not have the ApoE4 genotype.
Participants: Adults age 50-89 with Alzheimer's disease
Duration: One and a half years
Funding/Sponsor: Jeffrey Burns, M.D., MS (Site PI). Phase 3 clinical trial sponsored by Elan Pharmaceuticals.
Results: Bapineuzimab infusion did not alter cognitive or functional performance compared to a placebo in the study group. More information available at ClinicalTrials.gov


Elan 302

Goal: The study investigated a drug called Bapineuzimab, a therapy aimed at slowing Alzheimer's disease progression with an infusion of antibodies that target the amyloid protein, which accumulates in the brain of individuals with Alzheimer's disease. This study targeted people who did have the ApoE4 genotype.
Participants: Adults age 50-89 with Alzheimer's disease.
Duration: Visits every six weeks over a period of 78 weeks and five study drug infusions.
Funding/Sponsor: Jeffrey Burns, M.D., MS (Site PI). Phase 3 clinical trial sponsored by Elan Pharmaceuticals.
Results: Bapineuzimab infusion did not alter cognitive or functional performance compared to a placebo in the study group. More information may be available at ClinicalTrials.gov


Parkinson's Disease and Dementia Imaging Study

Goal: To investigate brain structure markers of Parkinson's disease that are associated with dementia.
Participants: 24 adults with Parkinson's disease, 12 of whom also have associated memory problems. Participants are between ages of 55-85 and do not have diabetes.
Duration: Three visits
Investigator: Robyn Honea, DPhil
Funding/Sponsor: A generous gift from the Heineman Family
Observations/conclusions: Results not yet available


S-Connect Medical Food

Goal: Examines whether medical food, Souvenaid, is beneficial for people with mild to moderate Alzheimer's disease who are already taking anti-Alzheimer's disease medications. 
Participants: Age 50+
Duration: Six months
Investigator/Sponsor: Jeffrey Burns, M.D. (Site PI). Danone Research
Observations/conclusions: Souvenaid did not show the expected effect in individuals with mild-to-moderate Alsheimer's disease, but the results beneficial effect on cognition in a subgroup of patients with worse cognitive function at the beginning of the study.


Cognitive Re-Training

Goal: Examine if repetitive, cognitive retraining is beneficial in people with early Alzheimer's disease. 
Participants: Adults age 60+ with early Alzheimer's disease
Duration: Two weeks
Investigator/Sponsor: Patricia Pohl, PT, Ph.D. Alzheimer's Association
Results: Not yet available.


Summit AD Study

Goal: Evaluate the drug, bapineuzumab administered subcutaneuously, in treating the symptoms of Alzheimer's disease. 
Participants: Adults age 50+ with Alzheimer's disease
Duration: Two years
Investigator/Sponsor: Jeff Burns, M.D., MS (Site PI). Janssen Alzheimer Immunotherapy Research & Development, LLC
Results: Not yet available. More information available at ClinicalTrials.gov


Alzheimer's Disease Neuroimaging Initiative (ADNI)
This national study is examining how brain imaging and other tests can measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease. This study will determine the effectiveness of these measures in recognizing the earliest changes of Alzheimer's and develop methods to measure Alzheimer's progression for future treatment studies.  Enrolled participants must be over the age of 55 and can have no memory problems, mild cognitive impairment or mild Alzheimer's disease. This study lasts 2 - 3 years with visits approximately every 6 months.  Enrollment is closed. 28 participants are currently enrolled


Fluency Study
This study's goals are to evaluate thinking abilities in participants with early Alzheimer's disease. 17 participants are currently enrolled.


Elan 201
This study is evaluating the oral form of the study drug and its effect on decreasing beta amyloid (protein) deposits in the brains of subjects with Alzheimer's disease. 3 participants are currently enrolled.


Antioxidant Defense in Alzheimer's
This study examines the brain using a novel neuroimaging technique that measure brain chemicals related to oxidative stress. The goal is to measure concentrations of an important antioxidant called Glutathione and to understand how specific chemical changes occur in the progression of Alzheimer's disease.


Alzheimer Disease Exercise Program Trial (ADEPT)
Dr. Heather Anderson, an Alzheimer & Memory Program physician is conducting the Alzheimer Disease Exercise Program Trial (ADEPT). This study is assessing the impact of a supervised exercise program in early Alzheimer's disease. Individuals 60 and older with memory problems are being enrolled in this 3-month trial. Enrolled participants will participate in exercise sessions with an exercise specialist three days a week at Kirmayer Fitness Center on the KUMC campus. The project is sponsored by Oppenheimer Brothers Foundation and the KU Research Institute.


American Indian Study
This study is enrolling 30 American Indians, 50 and older without memory problems. The participants will have physical fitness and paper and pencil memory testing. There is an option of the participant having a brain MRI. The purpose of this study is to investigate the role of lifestyle on brain health in the American Indian.

Last modified: Oct 10, 2012
ID=x4128