Parkinson Disease
Conditions
Keywords
11C-PIB, Parkinson's disease, dementia, mild cognitive impairment
Brief summary
To evaluate the potential contribution of amyloid burden, as indexed by 11C-Pittsburgh compound B (PiB) retention, to the progression of cognitive impairments in patients with Parkinson's disease(PD).
Detailed description
Study design: Multi-center, Five-arm Subjects: Patients with PD without dementia; Patients with PD with mild cognitive impairment (MCI); Patients with PD with dementia; Patients with a dementia with Lewy bodies(DLB); Healthy person Sample size: 200, including a PD without dementia group of 75 patients, a PD with MCI group of 30 patients, a PD with dementia group of 20 patients, a DLB group of 25 patients and a normal control group of 50 subjects.
Interventions
DRUG11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
Sponsors
Oriental Neurosurgery Evidence-Based-Study Team
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients with Parkinson's disease and parkinsonian dementia syndromes 2. Males and females, ≥40 years old 3. The diagnosis of PD is established using the UK Parkinson's Disease Society Brain Bank Research Center Clinical diagnostic criteria. Criteria for PD-MCI and PD-dementia are consistent with those of the Movement Disorder Society. The DLB Consortium consensus criteria are used for DLB. 4. They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.
Exclusion criteria
1. Females planning to bear a child recently or with childbearing potential 2. Renal function: serum creatinine \>3.0 mg/dL (270 μM/L) 3. Liver function: any hepatic enzyme level more than 5 times upper limit of normal. 4. Known severe allergy or hypersensitivity to IV radiographic contrast. 5. Patients not able to enter the bore of the PET/CT scanner. 6. Inability to lie still for the entire imaging time because of cough, pain, etc. 7. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. 8. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amyloid burden range in all subjects | 1 week | Outcome Measures: All patients underwent a 90-min dynamic 11C-PIB PET scan. 11C-PiB distribution volume ratio (DVR) will be estimated by using the PMOD software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The cognitive scores in all patients | 0, 6month, 1year | Functional status is assessed by the Mini-Mental State Examination (MMSE). Parkinson disease with mild cognitive impairment：MMSE score 24-28; Parkinson disease with dementia: MMSE score ≤24; Parkinson disease with normal cognition: MMSE score \>28. |
Countries
China
Contacts
Primary ContactLi Cai, PhD
Outcome results
None listed