[PETDE10] Imaging of PDE10A Enzyme Levels in Huntington's Disease Gene Expansion Carriers and Healthy Controls With PET. (PEARL-HD)
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ClinicalTrials.gov Identifier: NCT02061722 |
Recruitment Status :
Completed
First Posted : February 13, 2014
Last Update Posted : June 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Huntington's Disease | Radiation: PET Imaging with [18F]MNI-659 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | [PETDE10] Imaging of Phosphodiesterase 10 A (PDE10A) Enzyme Levels in the Living Human Brain of Huntington´s Disease Gene Expansion Carriers and Healthy Controls With Positron Emission Tomography |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: PET Imaging with [18F]MNI-659
All subjects (both HDGECs and HCs) will receive single intravenous doses of the radioligands [11C]raclopride (non-investigational medicinal product [NIMP]) and [18F]MNI-659 (investigational medicinal product [IMP]). The radioligands [11C]raclopride and [18F]MNI-659 will be administered at doses less than 10 micrograms, i.e. within the micro dosing concept, and no pharmacological effects are expected. The injected radioactivity of [11C]raclopride will be 300 MBq/70 kg of body weight ± 10%. The injected radioactivity of [18F]MNI-659 will be 185 MBq/70 kg of body weight ± 10%. |
Radiation: PET Imaging with [18F]MNI-659
The radioligands [11C]raclopride and [18F]MNI-659 will be administered at doses less than 10 micrograms, i.e. within the micro dosing concept, and no pharmacological effects are expected. The injected radioactivity of [11C]raclopride will be 300 MBq/70 kg of body weight ± 10%. The injected radioactivity of [18F]MNI-659 will be 185 MBq/70 kg of body weight ± 10%. |
- The primary outcome measure will be the distribution volume (VT) in the striatum (caudate and putamen), globus pallidus, and ventral striatum estimated using kinetic and graphical analysis. Thalamus, cortex and cerebellum will also be examined. [ Time Frame: Visit 3: For HD subjects, this will occur within 90 days from the Screening Visit. For Healthy Controls, this will occur within 28 days of Screening visit. ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Capacity to give full informed consent in writing, and have read and signed the informed consent
- Age 18 to 70 years, inclusive
- HCs: Healthy according to medical history, physical examination, ECG, vital signs, laboratory assessment and MRI, with a body mass index between 19 and 27 (both inclusive)
- HDGECs: Otherwise healthy according to medical history, no co-morbidity of psychotic disorders, physical examination, vital signs and laboratory assessments
- HDGECs:
(A) HD Stage 1 or HD Stage 2: Patients with a clinical diagnosis of HD, defined by the presence of noticeable motor disorder and 40 CAG repeats (HD stage 1: Total Functional Capacity (TFC) 11-13, HD stage 2: TFC 7-10); (B) Pre-manifest: Subjects that are carriers of the mutant Huntingtin gene with ≥40 CAG repeats, a disease burden score ≥ 275 (calculated by the equation ((CAGn-35.5) X age)), and a Total Motor Score (TMS) ≤ 5.
- Able and willing to travel to Stockholm
- Willing to comply with 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 with the exception for Viagra, Levitra and Cialis, which may be temporarily discontinued prior to the PET measurements
- HDGECs: History of other neurological condition (including brain surgery, intracranial haematoma, stroke/cerebrovascular disorders, epilepsy), co-morbidity of psychotic disorders
- HCs: Anamnesis/medical history of neurological conditions (Alzheimer´s disease, dementia, Parkinson´s disease, brain surgery, intracranial haematoma, stroke/cerebrovascular disorders, epilepsy) or psychiatric conditions schizophrenia, depression, bipolar disorder, attention-deficit hyperactivity disorder)
- HCs: Family history of HD
- History of or current alcohol or drug abuse or dependence
- History of anaphylactoid or anaphylactic reactions to any allergen including drugs and contrast media
- Haematological or biochemical parameters that are outside the normal range and are considered clinically significant by the Investigator
- Clinical relevant findings in the 12-lead ECG as determined by the evaluating physician
- Donation of blood (450 mL) within three months prior to Visit 3
- Contraindication to MRI, such as known claustrophobia, presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes
- Participating in a clinical trial within the past 3 months
- HCs: previous participation in another PET study
- Positive viral test result for Hepatitis B or C or HIV 1 or 2
- Female subjects: breast-feeding or positive pregnancy test at screening or at Visit 3
- Contraindication for arterial cannulation (by assessment of Allen's test)

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): NCT02061722
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 | |
KTA Karolinska Trial Alliance | |
Stockholm, Sweden, SE-171 76 | |
Neurologkliniken Akademiska sjukhuset, ing 85 | |
Uppsala, Sweden, SE-751 85 |
Principal Investigator: | Bernhard Landwehrmeyer, MD, PhD | Ulm University Hospital | |
Study Director: | Cristina Sampaio, MD, PhD | CHDI Foundation, Inc. |
Responsible Party: | CHDI Foundation, Inc. |
ClinicalTrials.gov Identifier: | NCT02061722 |
Other Study ID Numbers: |
CHDIKI1201/PET-HD-PDE10A |
First Posted: | February 13, 2014 Key Record Dates |
Last Update Posted: | June 1, 2016 |
Last Verified: | March 2016 |
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 |