Trial Outcomes & Findings for Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease (NCT NCT01106976)

Results Overview

AChE PMP PET hydrolysis rate outcome measure. AChE \[11C\]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.

Recruitment status

COMPLETED

Target enrollment

67 participants

Primary outcome timeframe

4 yr

Results posted on

2016-02-01

Participant Flow

67 patients with Parkinson disease

Patient with Parkinson disease with no contra-indication for MRI.

Participant milestones

Participant milestones
Measure	Group 1 Parkinson Disease Subjects Prospective cohort study. 59 PD patients; Hoehn and Yahr stage 1-3) underwent \[C-11\]methyl-4-piperidinyl propionate (PMP) acetylcholinesterase (AChE) brain PET imaging at baseline and at 3-4 year follow-up. AChE PET imaging assesses cholinergic terminal integrity with cortical uptake reflecting largely basal forebrain neuron integrity and thalamic uptake principally reflecting pedunculopontine nucleus integrity.
Overall Study STARTED	67
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Parkinson Disease Subjects Prospective cohort study. 59 PD patients; Hoehn and Yahr stage 1-3) underwent \[C-11\]methyl-4-piperidinyl propionate (PMP) acetylcholinesterase (AChE) brain PET imaging at baseline and at 3-4 year follow-up. AChE PET imaging assesses cholinergic terminal integrity with cortical uptake reflecting largely basal forebrain neuron integrity and thalamic uptake principally reflecting pedunculopontine nucleus integrity.
Overall Study Lost to Follow-up	8

Baseline Characteristics

Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Parkinson Disease Subjects n=67 Participants Prospective cohort study. 59 PD patients
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	53 Participants n=5 Participants
Age, Continuous	66.7 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 yr

Population: Parkinson disease.

AChE PMP PET hydrolysis rate outcome measure. AChE \[11C\]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.

Outcome measures

Outcome measures
Measure	Parkinson Disease n=59 Participants Prospective cohort study of Parkinson disease subjects.
AChE PET Neuroimaging baseline forebrain cortical AChE activity	0.0238 1/min Standard Deviation 0.0029
AChE PET Neuroimaging 4-yr forebrain cortical AChE follow-up activity	0.0226 1/min Standard Deviation 0.0032

Adverse Events

Parkinson

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Parkinson n=67 participants at risk Longitudinal cohort
Psychiatric disorders scanner claustrophobia	1.5% 1/67 • Number of events 1 • 1.5-4 yr

Additional Information

Nicolaas Bohnen

VAAAHS

Phone: 7349988400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place