11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes
NCT ID: NCT03555292
Last Updated: 2018-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2017-07-12
2021-10-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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PD without dementia
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.
11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
PD with MCI
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.
11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
PD with dementia
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.
11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
dementia with Lewy bodies
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.
11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
healthy control
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.
11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
Interventions
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11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
Eligibility Criteria
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Inclusion Criteria
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
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.
\-
18 Years
ALL
Yes
Sponsors
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Oriental Neurosurgery Evidence-Based-Study Team
OTHER
Responsible Party
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Principal Investigators
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Shuo Gao, MD
Role: STUDY_DIRECTOR
Tianjin Medical University General Hospital
Locations
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Peking Tian Tan Hospital, Capital Medical University
Beijing, , China
Tianjin Huanhu Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
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Central Contacts
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Other Identifiers
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CPBD2018
Identifier Type: -
Identifier Source: org_study_id
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