Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-25 @ 5:37 PM
Study NCT ID:
NCT03741920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status
Sponsor:
Global Kinetics Corporation
Organization:
Study Overview
Official Title:
Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
APPRISE
Brief Summary:
The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically:
1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group).
2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.
1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group).
2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.
Detailed Description:
This is a prospective, multicenter, randomized controlled trial. The study consists of 3 phases as follows:
* Randomization phase: subjects undergo screening, baseline, interim and 90-day follow-up visits
* PKG+ Group (standard of care clinical evaluation plus use of PKG data)
* PKG- Group (standard of care clinical evaluation without use of PKG data - the MDS is blinded to PKG data)
* Randomization ratio will be 1:1 with assignments generated in advance of the start of the trial by the unblinded statistician who will provide a list containing group assignments that will be available in an Electronic Database (EDC) for site use.
* The clinical investigator, study site staff, and subject will not be blinded to the randomization assignment during the randomization phase of the study
* Open-label phase: at the end of the 90-day randomization phase visit for PKG- Group subjects, the MDS will report on the PKG and review it with the subject, the subject will complete follow-ups with the MDS using the PKG information during the clinical assessment following the same process as the PKG+ Group during the randomization phase
* Extended open-label follow-up phase: annual follow-ups for all subjects at 1, 2, and 3 years during which the MDS will use the PKG information during clinical assessments for all subjects.
* Randomization phase: subjects undergo screening, baseline, interim and 90-day follow-up visits
* PKG+ Group (standard of care clinical evaluation plus use of PKG data)
* PKG- Group (standard of care clinical evaluation without use of PKG data - the MDS is blinded to PKG data)
* Randomization ratio will be 1:1 with assignments generated in advance of the start of the trial by the unblinded statistician who will provide a list containing group assignments that will be available in an Electronic Database (EDC) for site use.
* The clinical investigator, study site staff, and subject will not be blinded to the randomization assignment during the randomization phase of the study
* Open-label phase: at the end of the 90-day randomization phase visit for PKG- Group subjects, the MDS will report on the PKG and review it with the subject, the subject will complete follow-ups with the MDS using the PKG information during the clinical assessment following the same process as the PKG+ Group during the randomization phase
* Extended open-label follow-up phase: annual follow-ups for all subjects at 1, 2, and 3 years during which the MDS will use the PKG information during clinical assessments for all subjects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: