Decrease in Sense of Smell and Associated Cognitive Decline in Parkinson's Disease (OLF)
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Purpose
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 Parkinson's Disease (PD) and that worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals of this project, patients with PD without dementia will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE [11C]PMP 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 2 years (± 6 months). Annual olfactory testing will be performed to better understand dynamic changes underlying the clinical and PET outcome measures.
| Condition |
|---|
|
Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD |
- Olfactory testing [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
saliva
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Parkinson disease group
Subjects with Parkinson disease
|
Detailed Description:
Smell functions will be assessed using a test battery of odor identification, odor memory, and odor discrimination tests.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Movement Disorders Clinic, Hospital, Primary Care, Community
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
Contacts and Locations| United States, Michigan | |
| Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Christine Minderovic, BS, RT, CNMT 734-998-8420 cmindero@umich.edu | |
| Contact: Jamie Miller, BS 734-998-8400 jamieann@umich.edu | |
| Sub-Investigator: Roger Albin, M.D. | |
| Sub-Investigator: Martijn Muller, Ph.D. | |
| Principal Investigator: | Nicolaas Bohnen, M.D., Ph.D. | University of Michigan |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nicolaas Bohnen, MD, PhD, Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01572142 History of Changes |
| Other Study ID Numbers: | R01N5070856 |
| Study First Received: | April 3, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Parkinson disease smell cognitive |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 16, 2013