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

Oriental Neurosurgery Evidence-Based-Study Team

Status and phase: Unknown; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: 11C-PiB

Study type: Interventional

Funder types: Other

Identifiers

NCT03555292

CPBD2018

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 5 patient groups

PD without dementia

Experimental group

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.

Treatment:

Drug: 11C-PiB

PD with MCI

Experimental group

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.

Treatment:

Drug: 11C-PiB

PD with dementia

Experimental group

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.

Treatment:

Drug: 11C-PiB

dementia with Lewy bodies

Experimental group

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.

Treatment:

Drug: 11C-PiB

healthy control

Experimental group

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.

Treatment:

Drug: 11C-PiB