[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 - PET-study PDE10A

CHDI foundation0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•- 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.

发起方

CHDI foundation