Clinical trial NCT01754168: Amyloid Beta and Cognition in Parkinson Disease
Official title: The Role of Amyloid Beta in the Progression of Cognitive Impairment in PD: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Neurological Disorders
Keywords: Parkinson disease
Cognition
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UM and VA Movement Disorders Clinic

Primary Care Clinic

Community

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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Primary outcomes:
measure: Cholinergic innervation
timeFrame: Change from Baseline in cholinergic innervation at 2 years
measure: Cortical Amyloid Beta plaques
timeFrame: Change from Baseline in beta-amyloid deposition at 2 years
measure: Cognitive function
timeFrame: Change from Baseline in cognitive function at 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nicolaas Bohnen, M.D., Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Roger Albin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Martijn Muller, PhD
role: PRINCIPAL_INVESTIGATOR
References: