University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT01754168
The investigators propose to study persons with Parkinson Disease (PD) with detailed clinical, cognitive and imaging at the time of study entry and repeat these assessments 2 years later. The study looks at how changes in activity of the neurotransmitter acetylcholine relates to changes in cognitive function and to see if there is presence or build up of amyloid protein.
Looking for future studies?
Notify Me65 year–99 year
All sexes
Observational
Ann Arbor, Michigan, 48109, United States
Participants with PD will be studied at initial visit assessing clinical, cognitive, and brain imaging. A one year and, if applicable, three year cognitive assessment will be done, and the entire/complete assessment (same as initial visit) will be repeated again at two years. There will be a maximum of three follow up visits. The imaging test battery will consist of amyloid and acetylcholine brain PET and MRI scans. The use of acetylcholine PET imaging will demonstrate how changes in activity of this neurotransmitter relate to changes in cognitive functions, such as memory and mental concentration. A key question will be whether persons with PD who not only are losing acetylcholine brain cells but also have the buildup of the Alzheimer amyloid protein have a more rapid progression with more severe cognitive decline and behavioral changes compared to persons who do not have the amyloid protein.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
PD diagnosis according to the UK PD Society of Brain Bank research Center criteria PD subjects at risk for dementia Age 50 and above, male or female Absence of dementia confirmed by clinical and detailed neurological assessment -
Exclusion criteria
Subjects with contra-indications to MR imaging Evidence of large vessel stroke or mass on on MRI Use of cholinergic or neuroleptic drugs at baseline Evidence of atypical parkinsonism on neurological exam Subjects limited by participation in research procedures involving ionizing radiation Pregnancy(test within 48 hours of each PET session) or breastfeeding
-
Time frame: Change from Baseline in cholinergic innervation at 2 years
FEOBV PET scan
Time frame: Change from Baseline in beta-amyloid deposition at 2 years
PIB PET scan
Time frame: Change from Baseline in cognitive function at 2 years
Detailed neuropsychological test battery
University of Michigan
Other
The Role of Amyloid Beta in the Progression of Cognitive Impairment in PD: A Prospective Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04760769
Basal Ganglia Diseases, Brain Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT02445651
Basal Ganglia Diseases, Brain Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT04223193
Basal Ganglia Diseases, Brain Diseases
Fresno, California, United States
View Trial DetailsNCT05951985
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Fort Smith, Arkansas, United States
View Trial Details