11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: 11C-PiB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Parkinson's disease and parkinsonian dementia syndromes Males and females, ≥40 years old 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. 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: Females planning to bear a child recently or with childbearing potential Renal function: serum creatinine >3.0 mg/dL (270 μM/L) Liver function: any hepatic enzyme level more than 5 times upper limit of normal. Known severe allergy or hypersensitivity to IV radiographic contrast. Patients not able to enter the bore of the PET/CT scanner. Inability to lie still for the entire imaging time because of cough, pain, etc. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD without dementia<br>11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection. | Drug: 11C-PiB<br>* 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans<br>|
| Experimental: PD with MCI<br>11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection. | Drug: 11C-PiB<br>* 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans<br>|
| Experimental: PD with dementia<br>11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection. | Drug: 11C-PiB<br>* 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans<br>|
| Experimental: dementia with Lewy bodies<br>11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection. | Drug: 11C-PiB<br>* 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans<br>|
| Experimental: healthy control<br>11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection. | Drug: 11C-PiB<br>* 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyloid burden range in all subjects | 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cognitive scores in all patients | 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. | 0, 6month, 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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11C-PIB, Parkinson's disease, dementia, mild cognitive impairment