Ignite Creation Date:
2024-05-06 @ 12:47 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03840837
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2019-02-11
Brief Title:
Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Cholinergic Neurotransmission - A Common Underlying Mechanism of Cognitive and Gait Impairment in Parkinson Disease
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-site non-randomized open label pilot study The investigators will use accelerometer-based instrumented gait analysis and computerized cognitive testing to study the interaction of motor and cognitive dysfunction in Parkinson disease dementia PDD and the effect of rivastigmine on motor and cognitive performance All study participants will be tested for motor and cognitive performance at baseline arm 1 A subgroup of study participants will then be treated with rivastigmine for 12 weeks arm 2 and the effect of this treatment on gait measures and cognitive measures will be analyzed at the follow-up visit 12 weeks after the baseline visit Specifically we will determine which components of motor and cognitive impairment are associated with each other and which components of the two domains respond to rivastigmine-mediated stimulation of cholinergic neurotransmission
Detailed Description:
This is a single-site non-randomized open label clinical trial in patients with Parkinson disease PD and mild to moderate cognitive deficits designed to 1 identify associations between cognitive impairment and gait impairment and 2 identify cognitive domains and gait measures that improve after 12 weeks of treatment with rivastigmine Aim 1 will be addressed with a cross-sectional approach arm 1 baseline only all participants and aim 2 will be addressed with a longitudinal interventional approach arm 2 12 week-treatment with rivastigmine subgroup of participants
Patients with idiopathic Parkinson disease PD and mild to moderate cognitive deficits amounting to PD dementia PDD will be enrolled At baseline arm 1 all participants will perform the timed-up-and-go test TUG wearing a light-weight sensor device strapped to the lower back with a neoprene belt Participants will also complete a computerized cognitive test battery NeuroTrax Mild Cognitive Impairment Early Dementia Battery by MindStreams A subgroup of participants arm 2 will then be treated with transdermal rivastigmine for 12 weeks with dose increases every 4 weeks and titration up to 133 mg24h if tolerated The same assessment quantitative gait testing and NeuroTrax computerized cognitive test battery will be repeated after 12 weeks with the participant on a stable dose of transdermal rivastigmine
The investigators will analyze correlation of iTUG measures and cognitive measures at baseline cross-sectional analysis The investigators will also analyze change in iTUG measures and cognitive measures between baseline and follow-up for the subgroup of participants in arm 2 in other words before and after rivastigmine treatment longitudinal analysis
Patients with idiopathic Parkinson disease PD and mild to moderate cognitive deficits amounting to PD dementia PDD will be enrolled At baseline arm 1 all participants will perform the timed-up-and-go test TUG wearing a light-weight sensor device strapped to the lower back with a neoprene belt Participants will also complete a computerized cognitive test battery NeuroTrax Mild Cognitive Impairment Early Dementia Battery by MindStreams A subgroup of participants arm 2 will then be treated with transdermal rivastigmine for 12 weeks with dose increases every 4 weeks and titration up to 133 mg24h if tolerated The same assessment quantitative gait testing and NeuroTrax computerized cognitive test battery will be repeated after 12 weeks with the participant on a stable dose of transdermal rivastigmine
The investigators will analyze correlation of iTUG measures and cognitive measures at baseline cross-sectional analysis The investigators will also analyze change in iTUG measures and cognitive measures between baseline and follow-up for the subgroup of participants in arm 2 in other words before and after rivastigmine treatment longitudinal analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3P30AG028747-13S3 | NIH | None | httpsreporternihgovquickSearch3P30AG028747-13S3 |