Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02061722




Registration number
NCT02061722
Ethics application status
Date submitted
3/02/2014
Date registered
13/02/2014
Date last updated
1/06/2016

Titles & IDs
Public title
[PETDE10] Imaging of PDE10A Enzyme Levels in Huntington's Disease Gene Expansion Carriers and Healthy Controls With PET.
Scientific 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
Secondary ID [1] 0 0
CHDIKI1201/PET-HD-PDE10A
Universal Trial Number (UTN)
Trial acronym
PEARL-HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PET Imaging with [18F]MNI-659

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%.


Treatment: Other: 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%.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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.

Eligibility
Key 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:
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
CHDI Foundation, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bernhard Landwehrmeyer, MD, PhD
Address 0 0
Ulm University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02061722