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

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

11C-PiB

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring 11C-PIB, Parkinson's disease, dementia, mild cognitive impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.
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Sites / Locations

Peking Tian Tan Hospital, Capital Medical UniversityRecruiting
Tianjin Huanhu HospitalRecruiting
Tianjin Medical University General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

PD without dementia

PD with MCI

PD with dementia

dementia with Lewy bodies

healthy control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03555292

First Posted

April 24, 2018

Last Updated

May 31, 2018

Sponsor

Oriental Neurosurgery Evidence-Based-Study Team

1. Study Identification

Unique Protocol Identification Number

NCT03555292

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 12, 2017 (Actual)

Primary Completion Date

May 12, 2021 (Anticipated)

Study Completion Date

October 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oriental Neurosurgery Evidence-Based-Study Team

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

11C-PIB, Parkinson's disease, dementia, mild cognitive impairment

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD without dementia

Arm Type

Experimental

Arm Description

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.

Arm Title

PD with MCI

Arm Type

Experimental

Arm Description

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.

Arm Title

PD with dementia

Arm Type

Experimental

Arm Description

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.

Arm Title

dementia with Lewy bodies

Arm Type

Experimental

Arm Description

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.

Arm Title

healthy control

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

11C-PiB

Intervention Description

11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans

Primary Outcome Measure Information:

Title

Amyloid burden range in all subjects

Description

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.

Time Frame

1 week

Secondary Outcome Measure Information:

Title

The cognitive scores in all patients

Description

Time Frame

0, 6month, 1year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Cai, PhD

Phone

86-22-60362190

XCL242004@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuo Gao, MD

Organizational Affiliation

Tianjin Medical University General Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Peking Tian Tan Hospital, Capital Medical University

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Name

Tianjin Huanhu Hospital

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Name

Tianjin Medical University General Hospital

City

Tianjin

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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