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

NCT ID: NCT02956148

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-06
• Study Completion Date: 2017-10-05

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.

Conditions

Huntington's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Radioligand [18F]MNI-659

All subjects will receive a single intravenous dose of the radioligand [18F]MNI-659 (investigational medicinal product [IMP]) and undergo PET imaging.

The radioligand [18F]MNI-659 will be administered at a dose of less than 5 micrograms, i.e. within the micro dosing concept, and no pharmacological effects are expected.

The injected radioactivity of [18F]MNI-659 will be 185 MBq/70 kg of body weight ± 10%.

Group Type: EXPERIMENTAL

Radioligand [18F]MNI-659

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHDI Foundation, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Varrone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Cristina Sampaio, MD, PhD

Role: STUDY_DIRECTOR

CHDI Foundation, Inc.

Locations

The Memory Clinic, Rigshopitalet

Copenhagen, , Denmark

Leiden University Medical Center, Department of Neurology

Leiden, , Netherlands

University of Oslo, Nevrologisk poliklinikk

Oslo, , Norway

Skane Universitetssjukhus Lund, Neurologiska kliniken

Lund, , Sweden

Karolinska Universitetssjukhus, Huddinge

Stockholm, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Uppsala University Hospital

Uppsala, , Sweden

Countries

Denmark; Netherlands; Norway; Sweden

Other Identifiers

CHDIKI1401

Identifier Type: -

Identifier Source: org_study_id