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Completed

NCT Number: NCT02956148

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

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.

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Key information

Age range

18 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Memory Clinic, Rigshopitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radioligand [18F]MNI-659

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.

Primary outcomes

  1. 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.

    Time frame: 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

    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

Sponsors and collaborators

Lead sponsor

CHDI Foundation, Inc.

Other

Registry information

Official study 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)

Acronym: LONGPDE10

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2016
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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