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

Sponsor

Oriental Neurosurgery Evidence-Based-Study Team (Other)

Overall Status

Unknown status

CT.gov ID

NCT03555292

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

66.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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).

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 12, 2017

Anticipated Primary Completion Date :

May 12, 2021

Anticipated Study Completion Date :

Oct 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Amyloid burden range in all subjects [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

The cognitive scores in all patients [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	Country
1	Peking Tian Tan Hospital, Capital Medical University	Beijing	China
2	Tianjin Huanhu Hospital	Tianjin	China
3	Tianjin Medical University General Hospital	Tianjin	China