Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)

Not Applicable

Completed

Conditions: Alzheimer's Disease

Interventions: Behavioral: Stretching
Behavioral: Aerobic Exercise

Registration Number: NCT01128361

Lead Sponsor: Jeff Burns, MD

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stretching	Stretching	-
Aerobic Exercise	Aerobic Exercise	-

Primary Outcome Measures

Name	Time	Method
Memory Composite	week 0, 13, and 26	A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.
Cornell Scale for Depression in Dementia	Week 0, 13, and 26	The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.
Executive Function Composite	Week 0, 13, and 26	A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.
Disability Assessment for Dementia	Week 0, 13, and 26	This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.