Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584656
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Understanding Cerebral Blood Flow Dynamics for Alzheimers Disease Prevention Through Exercise
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understanding Cerebral Blood Flow Dynamics for Alzheimers Disease Prevention Through Exercise the FlADex Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
flADex
Brief Summary:
Dementia is one of the leading causes of disability worldwide Underlying biological mechanisms are crucial in preclinical stages of Alzheimers disease AD Alterations in cerebral blood flow CBF and their relationship with AD blood-based biomarkers may be fundamental at early stages of the pathology Physical exercise is a trigger to modify these biological mechanisms Therefore flADex aims to examine the acute effects of different types of exercise resistance vs aerobic vs control on CBF AD blood-based biomarkers and its cognitive implications in older adults The hypothesis is that acute resistance or aerobic exercise will fluctuate levels of blood-based biomarkers and will exert acute CBF changes combined with cognitive implications
Detailed Description:
The aging population is at an increasing risk of developing Alzheimers Disease AD which is characterized by cognitive decline and memory loss Current pharmacological treatments have targeted amyloid-beta Aβ and tau protein and have largely failed to halt or reverse the progression of AD This has led to a growing interest on examining additional underlying mechanisms responsible for the initiation of AD pathology in this preclinical stage such as cerebral blood flow CBF alterations or peripheral levels of AD blood-based biomarkers Parallelly exercise might act as a trigger for these potential underlying mechanisms of AD in older adults Thus this study seeks to explore the acute effects of different type of exercise on CBF blood-based biomarkers and its cognitive implications in older adults
FlADex is a counterbalanced crossover trial that will include 20 adults aged 68 to 83 with non-pathological brain amyloid status 12 centiloid and APOE e4 noncarriers Each participant will be included in all study conditions in a randomized order i moderate aerobic exercise between 60-70 of the Maximal Heart Rate HRmax ii resistance exercise 4-6 Moderate intensity of Rate of Perceived Exertion and iii control resting condition Each condition lasting 30 minutes will be performed once CBF will be assessed by magnetic resonance imaging using pseudo-continuous arterial spin labeling at pre-condition and at 3 consecutive times post-condition at 20 27 and 34 min Blood-based biomarkers Aβ42 Aβ40 p-tau217 p-tau181 GFAP NfL BDNF IGF-1 will be measured pre-condition and post-condition at 0 50 70 min Cognitive outcomes Flanker Test and Picture Sequence Memory Test and mood status feeling scale and POMS questionnaire will be measured pre and post condition
FlADex trial will shed light on the acute effects of different types of exercises on CBF and AD blood-based biomarkers before beta-amyloid accumulation We expect that aerobic and resistance exercise will have different effects on CBF dynamics and AD blood biomarker levels over time in older adults
FlADex is a counterbalanced crossover trial that will include 20 adults aged 68 to 83 with non-pathological brain amyloid status 12 centiloid and APOE e4 noncarriers Each participant will be included in all study conditions in a randomized order i moderate aerobic exercise between 60-70 of the Maximal Heart Rate HRmax ii resistance exercise 4-6 Moderate intensity of Rate of Perceived Exertion and iii control resting condition Each condition lasting 30 minutes will be performed once CBF will be assessed by magnetic resonance imaging using pseudo-continuous arterial spin labeling at pre-condition and at 3 consecutive times post-condition at 20 27 and 34 min Blood-based biomarkers Aβ42 Aβ40 p-tau217 p-tau181 GFAP NfL BDNF IGF-1 will be measured pre-condition and post-condition at 0 50 70 min Cognitive outcomes Flanker Test and Picture Sequence Memory Test and mood status feeling scale and POMS questionnaire will be measured pre and post condition
FlADex trial will shed light on the acute effects of different types of exercises on CBF and AD blood-based biomarkers before beta-amyloid accumulation We expect that aerobic and resistance exercise will have different effects on CBF dynamics and AD blood biomarker levels over time in older adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None