Decrease in Sense of Smell and Associated Cognitive Decline in Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/1/2017 |
| Start Date: | August 2010 |
| End Date: | July 2016 |
Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD
The overarching goal of this prospective cohort study is to test the hypotheses that greater
severity of hyposmia is associated with increased risk of cognitive decline in PD and that
worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals
of this project, patients with PD without dementia or at-risk of dementia or with dementia
will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE
[11C]PMP or VAchT (vesicular acetylcholine transporter) [F18]-FEOBV PET will be performed
both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be
performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will
be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be
performed to better understand dynamic changes underlying the clinical and PET outcome
measures.
severity of hyposmia is associated with increased risk of cognitive decline in PD and that
worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals
of this project, patients with PD without dementia or at-risk of dementia or with dementia
will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE
[11C]PMP or VAchT (vesicular acetylcholine transporter) [F18]-FEOBV PET will be performed
both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be
performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will
be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be
performed to better understand dynamic changes underlying the clinical and PET outcome
measures.
Smell functions will be assessed using a test battery of odor identification, odor memory,
and odor discrimination tests.
and odor discrimination tests.
Inclusion Criteria:
- Diagnosed with Parkinson disease
- Hoehn & Yahr stage 2 and higher, and/or duration of motor disease 5 years or longer
- 50 and older
Exclusion Criteria:
- other disorders which may resemble PD
- subjects with definite dementia
- subjects with unstable or severe medical disorders
- subjects receiving neuroleptic, anticholinergic, or cholinesterase inhibitor drugs
- subjects in whom MRI imaging is contraindicated
- subjects who have received ionizing radiation that would, together with the current
project exposures, exceed exposure limits permissible to research volunteers
- pregnant
We found this trial at
1
site
Ann Arbor, Michigan 48109
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