Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers

Huntington's Disease Clinical Trial

— LONGPDE10  

Official title:

Follow-up Measurement of Brain Phosphodiesterase 10 A (PDE10A) Enzyme Levels in Huntington´s Disease Gene Expansion Carriers, 18 to 28 Months After Initial Positron Emission Tomography (PET) Measurement in CHDIKI1201/PET-HD-PDE10A (NCT02061722)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956148
• Other study ID #: CHDIKI1401
• Status: Completed
• Phase: Early Phase 1
• Start date: September 6, 2015
• Est. completion date: October 5, 2017

Study information

• Verified date: October 2019
• Source: CHDI Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in HDGECs using the radioligand [18F]MNI-659. The study will be a follow-up, examining HDGECs from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial PET measurement.

Description:

The HDGECs will perform 2 study visits: Visit 1 (screening) and Visit 2 (PET analysis utilizing the radioligand [18F]MNI-659). There will also be 2 telephone follow ups; one after Visit 1 (telephone follow-up after screening) and one after Visit 2, (telephone follow-up after PET). Study visits and telephone follow-ups will take place during a maximum of 97 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 5, 2017
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 73 Years

Eligibility

Inclusion Criteria:

• Have participated in and completed study CHDIKI1201/PET-HD-PDE10A and are capable of providing informed consent or have a legal representative authorized to give consent on their behalf.

• Otherwise healthy according to medical history, no co-morbidity of psychotic disorders, physical examination, vital signs and laboratory assessments

• Willing to travel to Stockholm (with a companion if requested) for PET examinations

• Suitable physically and psychologically to travel to Stockholm and undergo PET examinations, as judged by the recruiting Investigator with attention given to symptoms of chorea and anxiety

• Willing to comply with the use of adequate contraceptive measures

Exclusion Criteria:

• Any disease, condition or concomitant medications that significantly compromises the function of the body systems and that, in the opinion of the Investigator might interfere with the conduct of the study or the interpretation

• Regular use of any medication prohibited by this protocol (selective or non-selective PDE inhibitors), with the exception for erectile dysfunction medication, which may be temporarily discontinued prior to the PET measurement

• History of anaphylactoid or anaphylactic reactions to any allergen including drugs and contrast media

• History of other neurological condition (including brain surgery, intracranial hematoma, stroke/cerebrovascular disorders, epilepsy), co-morbidity of psychiatric disorders

• Clinically relevant findings in hematological, biochemical testing or 12-lead ECG as determined by the evaluating physician

• Female subjects who are breast-feeding or have a positive pregnancy test at screening or at Visit 2

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Radiation:
• Radioligand [18F]MNI-659
The effective radiation dose for the injection of [18F]MNI-659 is approximately 5.6 mSv (approximately 2 years of background radiation in Sweden) for an average person weighing 70 kg.

Locations

Country	Name	City	State
Denmark	The Memory Clinic, Rigshopitalet	Copenhagen
Netherlands	Leiden University Medical Center, Department of Neurology	Leiden
Norway	University of Oslo, Nevrologisk poliklinikk	Oslo
Sweden	Skane Universitetssjukhus Lund, Neurologiska kliniken	Lund
Sweden	Karolinska Universitetssjukhus, Huddinge	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
CHDI Foundation, Inc.

Countries where clinical trial is conducted

Denmark,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The longitudinal changes of PDE10A enzyme availability in the caudate, putamen, and globus pallidus of Huntington's Disease Gene Expansion Carriers by comparison of the follow-up and initial PET measurements.	The HDGECs will perform 2 study visits; Visits 1 (screening) and Visit 2 (PET) and 2 telephone follow ups, one after Visit 1 (telephone follow-up after screening) and one after Visit 2, (telephone follow-up after PET) 18 to 28 months after the initial PET measurement conducted in the CHDIKI1201/PET-HD-PDE10A study. An individual subject's participation in this study will last for a maximum of 97 days	The follow up PET measurement can be performed from 18 to 28 months after the initial PET measurement that was performed in the CHDIKI/PET-HD-PDE10A Study