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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD without dementia | Experimental | 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. |
|
| PD with MCI | Experimental | 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. |
|
| PD with dementia | Experimental | 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. |
|
| dementia with Lewy bodies | Experimental | 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. |
|
| healthy control | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-PiB | Drug | 11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans |
|
| 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 |
| 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 |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Cai, PhD | Contact | 86-22-60362190 | XCL242004@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuo Gao, MD | Tianjin Medical University General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Tian Tan Hospital, Capital Medical University | Recruiting | Beijing | China | |||
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C475519 | 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole |
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| Tianjin Huanhu Hospital |
| Recruiting |
| Tianjin |
| China |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |