[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
- Conditions
- neurodegenerative movement disorder1002929910028037
- Registration Number
- NL-OMON41442
- Lead Sponsor
- CHDI foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
- 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 comorbidity of psychotic disorders, physical examination, vital signs and laboratory assessments, and with a body mass index (BMI) between 19 and 27 (both inclusive)
- (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 *36 CAG repeats (HD stage 1: TFC 11-13, HD stage 2: TFC 7-10); (B) Pre-manifest: Subjects that are carriers of the mutant Huntington gene with *40 CAG repeats, a Total Motor Score *5 and disease burden score of either * 250 (early pre-manifest) or a disease burden score * 275 (late pre-manifest); disease burden score is calculated with the equationa ((CAGn-35.5) X age))
- HDGECs and HCs: Any disease, condition, or concomitant medication 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 its interpretation.;- History of anaphylactoid or anaphylactic reactions to any allergen including drugs and contrast media.;- 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.;- HDGECs: History of other neurological condition (including brain surgery, intracranial haematoma, stroke/cerebrovascular disorders, epilepsy), co-morbidity of psychotic disorders.;- HCs: Family history of HD.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to measure the availability of the PDE10A enzyme in<br /><br>Huntington*s Disease (HD)gene expansion carriers (HDGECs) by estimating and<br /><br>comparing the distribution volume (VT) of the radioligand [18F]MNI-659 in the<br /><br>striatum (caudate and putamen), globus pallidus, ventral striatum including<br /><br>nucleus accumbens, thalamus, cortex and cerebellum in HDGECs and age (± 5<br /><br>years)- and gender-matched healthy controls (HCs).</p><br>
- Secondary Outcome Measures
Name Time Method