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

Phase 2

• Conditions: Parkinson Disease
• Interventions: Drug: 11C-PiB

• Registration Number: NCT03555292
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2017-07-12
• Status Verified: 2018-04
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-31
• Last Update Submitted: 2018-05-31
• Study First Posted: 2018-06-13
• Last Update Posted: 2018-06-13
• Primary Completion: 2021-05-12
• Study Completion: 2021-10-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PD without dementia	11C-PiB	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.
PD with MCI	11C-PiB	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.
PD with dementia	11C-PiB	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.
dementia with Lewy bodies	11C-PiB	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.
healthy control	11C-PiB	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Peking Tian Tan Hospital, Capital Medical University; 🇨🇳 Beijing, China

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China