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[PETDE10] Imaging of PDE10A Enzyme Levels in Huntington's Disease Gene Expansion Carriers and Healthy Controls With PET.

NCT02061722 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-06-01

No results posted yet for this study

Summary

The aim of this study is to measure the availability of the PDE10A enzyme in Huntington disease gene expansion carriers (HDGECs) using the recently developed radioligand \[18F\]MNI-659. The study will be cross-sectional, examining HDGECs at different stages of the disease (pre-manifest, stage 1 and stage 2), in comparison with Healthy Controls (HCs). The HDGECs included in this study will be recruited from the large database of the REGISTRY (NCT01590589) or ENROLL-HD (NCT01574053) studies.

Conditions

Interventions

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%.

Sponsors & Collaborators

  • CHDI Foundation, Inc.

    lead OTHER

Principal Investigators

  • Bernhard Landwehrmeyer, MD, PhD · Ulm University Hospital

  • Cristina Sampaio, MD, PhD · CHDI Foundation, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Denmark
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061722 on ClinicalTrials.gov