Clinical trial NCT01128361: Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)
Official title: Alzheimer's Disease Exercise Prevention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current project is a natural extension of a programmatic line of investigation into the relationship between exercise, brain aging, and AD that Dr. Burns has developed over the last four years. The current study will provide data to estimate expected effect sizes for power analyses and sample size calculations. It will also provide an opportunity to optimally design a larger trial that can be extended to multiple sites to more definitively examine the role of exercise as a therapy in AD. The current project's aims are an important and necessary developmental step given the lack of fitness data in AD and the limited knowledge of the mechanisms that may form the basis of an association between aerobic fitness and AD.


Eligibility criteria: Inclusion Criteria:

* Informed consent provided by the participant or the participant's legally acceptable representative
* Age 55 years or older
* Diagnosis of Probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
* Clinical Dementia Rating (CDR) of 0.5 (very mild) or 1 (mild dementia)
* Mini-Mental Status Exam Score of 16 to 30, inclusive.
* Rosen Modified Hachinski score of 4 or less
* Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. The caregiver must visit with the subject more than five times a week for the duration of the study.
* Underactive or sedentary as determined by a Telephone Assessment of Physical Activity.
* Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
* Stable doses of medications for at least 30 days prior to screening. Cholinesterase inhibitors and memantine are allowed provided the participant is on stable doses without clinically significant side effects for 60 days. Additionally, the participant and caregiver will agree, barring unforeseen circumstances, to continue the same regimen for the trial duration.
* Likely to participate in all scheduled evaluations and complete the 26 week program.

Exclusion Criteria:

* CDR 0.5 uncertain dementia (i.e., not meeting NINCDS-ADRDA criteria).
* Significant neurological disease, other than AD, that may affect cognition
* MRI or CT scan indicative of significant abnormalities that may explain cognitive decline (e.g., multiple lacunar infarcts or a single prior infarct \> 1 cm3, micro-hemorrhages or evidence of a prior hemorrhage \> 1 cm3, evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, or space-occupying lesion such as an arachnoid cyst or brain tumor)
* Current clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to DSM-IV criteria or significant psychiatric symptoms (e.g., hallucinations) that could impair the completion of the study. Individuals with depressive symptoms (Geriatric Depression Scale \< 6) and who do not meet criteria for major depression will be eligible.
* Current clinically-significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study
* History of clinically-evident stroke
* Clinically-significant infection within the last 30 days
* Myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the last two-years.
* Uncontrolled hypertension within the last 6 months
* History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
* History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
* Presence of contraindications for MRI scanning (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects) or claustrophobia
* Insulin-dependent diabetes mellitus
* Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program

Primary outcomes:
measure: Memory Composite
timeFrame: week 0, 13, and 26
measure: Executive Function Composite
timeFrame: Week 0, 13, and 26
measure: Disability Assessment for Dementia
timeFrame: Week 0, 13, and 26
measure: Cornell Scale for Depression in Dementia
timeFrame: Week 0, 13, and 26
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Burns, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morris JK, Vidoni ED, Johnson DK, Van Sciver A, Mahnken JD, Honea RA, Wilkins HM, Brooks WM, Billinger SA, Swerdlow RH, Burns JM. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial. PLoS One. 2017 Feb 10;12(2):e0170547. doi: 10.1371/journal.pone.0170547. eCollection 2017.