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

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ClinicalTrials.gov Identifier: NCT03555292
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Oriental Neurosurgery Evidence-Based-Study Team

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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: 11C-PiB Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Safety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : May 12, 2021
Estimated Study Completion Date : October 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans

Experimental: 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.
Drug: 11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans

Experimental: 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.
Drug: 11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans

Experimental: 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.
Drug: 11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans

Experimental: 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.
Drug: 11C-PiB
11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans




Primary Outcome Measures :
  1. Amyloid burden range in all subjects [ Time Frame: 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 Outcome Measures :
  1. The cognitive scores in all patients [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555292


Contacts
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Contact: Li Cai, PhD 86-22-60362190 XCL242004@126.com

Locations
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China
Peking Tian Tan Hospital, Capital Medical University Recruiting
Beijing, China
Tianjin Huanhu Hospital Recruiting
Tianjin, China
Tianjin Medical University General Hospital Recruiting
Tianjin, China
Sponsors and Collaborators
Oriental Neurosurgery Evidence-Based-Study Team
Investigators
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Study Director: Shuo Gao, MD Tianjin Medical University General Hospital

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Responsible Party: Oriental Neurosurgery Evidence-Based-Study Team
ClinicalTrials.gov Identifier: NCT03555292     History of Changes
Other Study ID Numbers: CPBD2018
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oriental Neurosurgery Evidence-Based-Study Team:
11C-PIB
Parkinson's disease
dementia
mild cognitive impairment
Additional relevant MeSH terms:
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Dementia
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders