[11C]Donepezil PET For Imaging The Autonomous Nervous Sys... | NCT02012595

Studies
[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease

NCT02012595

Sponsor

Per Borghammer

Status

Completed

Last Update Posted

Jun 2, 2015Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

[11C]donepezil PET

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-003775-35	EudraCT Number

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Nov 26, 2013

First Submission Date that Met QC Criteria

Dec 10, 2013

First Posted Date

Dec 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2015

Last Update Posted Date

Jun 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Per Borghammer, MD, ph.d.,DMSci, Aarhus University HospitalSponsor-Investigator

Lead Sponsor

Per BorghammerOTHER

Collaborators

Name	Class
Lundbeck Foundation	OTHER
Jascha Fonden	OTHER
Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

AIM: Investigate wether there are differences in the parasympathetic nervous system in Parkinsons patients compared to controls.

MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged 40-80 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. Then PET/CT scans with [11C]donepezil are conducted - once for the upper abdominal region and once for the head region. For evaluating the function of the parasympathetic nervous system gastric emptying time, heart rate variability and salivary flow will be measured. These measureless will be correlated to the PET findings.

PERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's patients		Participants with Parkinson's Disease	Other: [11C]donepezil PET
Healthy Controls		Healthy participants	Other: [11C]donepezil PET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[11C]donepezil PET	Other	Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil	Healthy Controls Parkinson's patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distribution volume of [11C]donepezil in internal organs	Our primary endpoint is the distribution volume of [11C]donepezil in internal organs (including salivary glands, heart, stomach and intestines) in Parkinson's patients compared to controls.	The distribution volume of [11C]donepezil is measured at "Day 1" by PET/CT scanning each participant. The data analysis is done when all participants have completed the study.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 40-80 years

Exclusion Criteria:

dementia,
psychiatric diseases,
serious medical illness including any type of previous cancer
any drug with known interaction with the autonomic nervous system
metal in the body (because of MRI scan)
pregnancy or breast feeding (because of radiation due to PET/CT)
known diseases of the salivary glands, stomach, intestines.
Prior major surgery to salivary glands, esophagus, stomach.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Parkinson's patients with moderate symptoms (diagnosis > 4 years earlier, bilateral disease). Will be recruited through department of neurology Aarhus University Hospital, Denmark.

Healthy controls recruited through local media.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Borghammer, MD, PhD,DMSc	Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided