Parkinson's Disease
Conditions
Keywords
PET, acetylcholine
Brief summary
The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.
Detailed description
The project will apply positron emission tomography (PET) of acetylcholinesterase to study non-dopaminergic (i.e. cholinergic) brain changes over time in subjects with Parkinson disease. Acetylcholinesterase PET imaging was used to assess cholinergic changes over time in this study. Acetylcholinesterase PET imaging is a diagnostic test as the investigator does not assign specific interventions to the subjects of the study based on the acetylcholinesterase PET. Therefore, this is an observational study as defined as following: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.
Interventions
None listed
Sponsors
University of Michigan
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria for PD. * Hoehn and Yahr stages 1-2.5 at initial recruitment in baseline study. * Absence of dementia confirmed by neuropsychological testing at initial recruitment in baseline study.
Exclusion criteria
* contra-indication for magnetic resonance study * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AChE PET Neuroimaging | 4 yr | 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. |
Countries
United States
Participant flow
Recruitment details
67 patients with Parkinson disease
Pre-assignment details
Patient with Parkinson disease with no contra-indication for MRI.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Parkinson Disease Subjects Prospective cohort study. 59 PD patients | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
Baseline characteristics
| Characteristic | Group 1 Parkinson Disease Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 53 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 66.7 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment United States | 67 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 67 |
| serious Total, serious adverse events | 0 / 67 |
Outcome results
Primary
AChE PET Neuroimaging
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.
Time frame: 4 yr
Population: Parkinson disease.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parkinson Disease | AChE PET Neuroimaging | baseline forebrain cortical AChE activity | 0.0238 1/min | Standard Deviation 0.0029 |
| Parkinson Disease | AChE PET Neuroimaging | 4-yr forebrain cortical AChE follow-up activity | 0.0226 1/min | Standard Deviation 0.0032 |
Comparison: Paired t-test. Hypothesis of significant cholinergic interval changes over the study interval period.p-value: 0.0009t-test, 1 sided