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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03555292
• Other study ID #: CPBD2018
• Status: Recruiting
• Phase: Phase 2
• Start date: July 12, 2017
• Est. completion date: October 12, 2021

Study information

• Verified date: April 2018
• Source: Oriental Neurosurgery Evidence-Based-Study Team
• Contact: Li Cai, PhD
• Phone: 86-22-60362190
• Email: XCL242004[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
China	Peking Tian Tan Hospital, Capital Medical University	Beijing
China	Tianjin Huanhu Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Oriental Neurosurgery Evidence-Based-Study Team

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week
Secondary	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.	0, 6month, 1year