[LONGPDE10] Follow-up measurement of brain phosphodiesterase 10 A (PDE10A) enzyme levels in Huntington*s disease gene expansion carriers, 18 to 28 months after initial PET measurement in CHDIKI1201/PET-HD-PDE10A

[LONGPDE10] Follow-up measurement of brain phosphodiesterase 10 A (PDE10A) enzyme levels in Huntington*s disease gene expansion carriers, 18 to 28 months after initial PET measurement in CHDIKI1201/PET-HD-PDE10A - Longitudinal PET study PDE10A

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43581

Enrollment

Registered

2016-04-04

Start date

2016-11-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurodegenerative movement disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: HDGECs who have participated in and completed study CHDIKI1201/PET-HD-PDE10A .

Exclusion criteria

Exclusion criteria: 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 other neurological condition (including brain surgery, intracranial haematoma, stroke/cerebrovascular disorders, epilepsy), co-morbidity of psychiatric disorders. History of anaphylactoid or anaphylactic reactions to any allergen including drugs and contrast media.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure will be the longitudinal change in binding potential (BPND) estimated with the Logan graphical analysis using the cerebellum as reference region.	—

Secondary

Measure	Time frame
The correlation between longitudinal changes of PDE10A enzyme availability (BPND) and longitudinal changes of clinical ratings (stage and UHDRS, total and subscores), and psychiatric and cognitive assessments. Cognitive/behaviour scales to be used: * From REGISTRY or ENROLL-HD: o PBA-S (Appendix A) o Cognitive Assessments: Verbal Fluency (letters), Verbal Fluency (Category), Stroop (colour naming, word reading, interference), Symbol-Digit. (Appendix B) o UHDRS (Appendix C; for TMS and TFC) * Not in REGISTRY or ENROLL-HD: o MOCA (Appendix D) The correlation between longitudinal changes of PDE10A enzyme availability (BPND) and the number of CAG repeats and disease duration (the classical definition of time when motor clinical manifestation first became noticeable will be used; applicable only in case of stage 1 and stage 2 subjects).	—

Measure

Time frame

The correlation between longitudinal changes of PDE10A enzyme availability (BPND) and longitudinal changes of clinical ratings (stage and UHDRS, total and subscores), and psychiatric and cognitive assessments. Cognitive/behaviour scales to be used: * From REGISTRY or ENROLL-HD: o PBA-S (Appendix A) o Cognitive Assessments: Verbal Fluency (letters), Verbal Fluency (Category), Stroop (colour naming, word reading, interference), Symbol-Digit. (Appendix B) o UHDRS (Appendix C; for TMS and TFC) * Not in REGISTRY or ENROLL-HD: o MOCA (Appendix D) The correlation between longitudinal changes of PDE10A enzyme availability (BPND) and the number of CAG repeats and disease duration (the classical definition of time when motor clinical manifestation first became noticeable will be used; applicable only in case of stage 1 and stage 2 subjects).

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Countries

Netherlands

Outcome results