Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587217
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Neurobiological Drivers of Mobility Resilience The Dopaminergic System - Supplemental Open-Label Arm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neurobiological Drivers of Mobility Resilience The Dopaminergic System
Status:
RECRUITING
Status Verified Date:
2024-09
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:
RES
Brief Summary:
Walking with age becomes both slower and less automated requiring more attention and brain resources As a result older adults have a greater risk of negative outcomes and falls There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments as there are currently no effective treatments available Investigators have recently discovered that 20 of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems thus appearing to be protected against these harmful factors The investigators work suggests that the brain dopamine DA system may be a source of this protective capacity Investigators have also shown that lower levels of dopamine are associated with slow walking Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this open-label study using detailed clinical assessment assessment of dopamine activity and clinical interventions
Detailed Description:
Walking with age becomes both slower and less automated requiring more attention and prefrontal resources As a result older adults have a greater risk of adverse mobility outcomes and falls Walking disturbances in the elderly have been linked to changes in both cerebral in particular small vessel disease cSVD and peripheral systems There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments as there are currently no effective treatments available Although effective mobility is the end result of the functional capacity of both central and peripheral systems the brains unique modulatory and adaptive capacity may provide clues for novel interventions For example investigators have recently discovered that 20 of older adults maintain fast walking speed even in the presence of age related cSVD and peripheral system impairments thus appearing resilient to these harmful factors The investigators work suggests that the nigrostriatal dopamine DA system may be a source of this resilience As investigators recent findings suggest DA neurotransmission positively predicts walking speed it also attenuates the negative effects of age related cSVD and peripheral system impairments on walking speed These findings are consistent with post-mortem evidence that a combination of loss of nigral DA neurons and cSVD best predict age-related walking impairment The nigrostriatal DA system plays a critical role in motor control nigrostriatal DA neurotransmission regulates the automated execution of overlearned motor tasks via its connections with sensorimotor cortical and subcortical areas
The investigators hypothesize that higher nigrostriatal DA neurotransmission drives resilience to cSVD and peripheral system impairments via higher connectivity of sensorimotor networks thus increasing automaticity of walking and reducing prefrontal engagement while walking Unlike cSVD and brain structural impairments DA neurotransmission is potentially modifiable thereby offering novel approaches to treat non-resilient elderly in a targeted fashion This study is an arm of a previously completed translational pilot biomechanistic target engagement study in older adults with slow walking andor parkinsonian signs NCT04325503 This sub-study will further expand upon biomechanistic target engagement findings by increasing the sample size using an additional open-label experimental design
The study will include elderly men and women age 60 or older with evidence of mild parkinsonian signs MPS or slow gait 1ms
The investigators hypothesize that higher nigrostriatal DA neurotransmission drives resilience to cSVD and peripheral system impairments via higher connectivity of sensorimotor networks thus increasing automaticity of walking and reducing prefrontal engagement while walking Unlike cSVD and brain structural impairments DA neurotransmission is potentially modifiable thereby offering novel approaches to treat non-resilient elderly in a targeted fashion This study is an arm of a previously completed translational pilot biomechanistic target engagement study in older adults with slow walking andor parkinsonian signs NCT04325503 This sub-study will further expand upon biomechanistic target engagement findings by increasing the sample size using an additional open-label experimental design
The study will include elderly men and women age 60 or older with evidence of mild parkinsonian signs MPS or slow gait 1ms
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