Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease

Alzheimer Disease Clinical Trial

— AEROBIC  

Official title:

Acute Exercise Response On Brain Imaging and Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299308
• Other study ID #: STUDY00142140
• Secondary ID: 1R01AG062548-01A
• Status: Completed
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal is to characterize the acute exercise response as it relates to brain glucose metabolism in aging and Alzheimer's Disease (AD). The study team will also examine lactate metabolism, relationships with cognition, and the effect of exercise intensity.

Description:

Aim 1: Compare the effects of acute, moderate intensity and acute, higher intensity exercise on cerebral glucose metabolism in nondemented (ND) elderly and AD subjects. ND (n=30) and AD (n=30) subjects will undergo a single bout of moderate intensity (45-55% HRR) or higher intensity (65-75% HRR) exercise to assess the effect of exercise intensity on acute change in brain glucose metabolism (rest to exercise). Investigators hypothesize that both moderate and high intensity exercise will elicit a drop in global brain glucose metabolism compared to quiet rest, but that the effect will be greater with higher intensity vs. moderate intensity exercise, and greater in ND subjects than in AD subjects.

Aim 2: Characterize the effect of both exercise intensities on acute biomarker response and cognition (memory and executive function) in ND and AD subjects. The acute biomarker response to exercise and the effect on cognition has not been examined in aged or AD cohorts. Investigators hypothesize that acute higher intensity exercise will elicit a greater blood lactate response (area under the curve, AUC) compared to acute moderate intensity exercise, and that this response will be greater in ND than in AD subjects. Investigators further hypothesize that lactate AUC will track negatively with change in cerebral glucose metabolism and cognitive performance. Although investigators will focus on lactate, they will also quantify additional exercise-related biomarkers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age 60 and older

• Stable medication doses (>1month)

• Post-menopausal

• Diagnosis of either Nondemented (CDR 0) or Probable AD (CDR 0.5 or 1 only)

Exclusion Criteria:

• Inability to provide consent

• Diagnosis of insulin-dependent (Type 1) Diabetes Mellitus

• Recent ischemic heart disease (<2 years)

• Diagnosis of an clinically significant chronic disease including cardiovascular disease (CVD), other metabolic diseases (e.g., thyroid), cancer, human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome

• Excluded from or unable to complete an MRI scan

• Any Neurological disorders that have the potential to impair cognition or brain metabolism (e.g., Parkinson's disease, stroke defined as a clinical episode with neuroimaging evidence in an appropriate area to explain the symptoms).

• Clinically significant depressive symptoms that may impair cognition, abnormalities in B12, rapid plasma regain (RPR), or thyroid function that may impair cognition, use of psychoactive and investigational medications, and significant visual or auditory impairment

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy Aging

Intervention

Behavioral:
• Aerobic Exercise
Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload

Locations

Country	Name	City	State
United States	Univeristy of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio)	FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) will be calculated from native-space region of interest (ROI).	Resting Vs acute exercise bout: ~1 month
Secondary	Lactate Area Under the Curve	Change in circulating lactate	Resting Vs acute exercise bout: ~1 month
Secondary	Brain-derived neurotrophic factor (BDNF) Change	Change in circulating Brain Derived Neurotrophic Factor	Resting Vs acute exercise bout: ~1 month