Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers (LONGPDE10)
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| ClinicalTrials.gov Identifier: NCT02956148 |
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Recruitment Status :
Completed
First Posted : November 7, 2016
Last Update Posted : October 10, 2019
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Sponsor:
CHDI Foundation, Inc.
Information provided by (Responsible Party):
CHDI Foundation, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Huntington's Disease | Radiation: Radioligand [18F]MNI-659 | Early Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 45 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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) |
| Actual Study Start Date : | September 6, 2015 |
| Actual Primary Completion Date : | October 5, 2017 |
| Actual Study Completion Date : | October 5, 2017 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Huntington disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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%. |
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. |
Primary Outcome Measures :
- 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
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| Ages Eligible for Study: | 18 Years to 73 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956148
Locations
| Denmark | |
| The Memory Clinic, Rigshopitalet | |
| Copenhagen, Denmark | |
| Netherlands | |
| Leiden University Medical Center, Department of Neurology | |
| Leiden, Netherlands, K5Q112 | |
| Norway | |
| University of Oslo, Nevrologisk poliklinikk | |
| Oslo, Norway, 0372 Oslo | |
| Sweden | |
| Skane Universitetssjukhus Lund, Neurologiska kliniken | |
| Lund, Sweden, SE-221 85 | |
| Karolinska Universitetssjukhus, Huddinge | |
| Stockholm, Sweden, SE-141 86 | |
| Karolinska University Hospital | |
| Stockholm, Sweden, SE-171 76 | |
| Uppsala University Hospital | |
| Uppsala, Sweden | |
Sponsors and Collaborators
CHDI Foundation, Inc.
Investigators
| Principal Investigator: | Andrea Varrone, MD, PhD | Karolinska University Hospital | |
| Study Director: | Cristina Sampaio, MD, PhD | CHDI Foundation, Inc. |
| Responsible Party: | CHDI Foundation, Inc. |
| ClinicalTrials.gov Identifier: | NCT02956148 History of Changes |
| Other Study ID Numbers: |
CHDIKI1401 |
| First Posted: | November 7, 2016 Key Record Dates |
| Last Update Posted: | October 10, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Chorea Dyskinesias |
Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders |