Clinical trial NCT02956148: Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Huntington's Disease
Lead sponsor: CHDI Foundation, Inc.
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Memory Clinic, Rigshopitalet
city: Leiden
country: Netherlands
facility: Leiden University Medical Center, Department of Neurology
city: Oslo
country: Norway
facility: University of Oslo, Nevrologisk poliklinikk
city: Lund
country: Sweden
facility: Skane Universitetssjukhus Lund, Neurologiska kliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhus, Huddinge
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Andrea Varrone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHDI Foundation, Inc.
name: Cristina Sampaio, MD, PhD
role: STUDY_DIRECTOR
References: