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Completed

NCT Number: NCT04701580

Synaptic Density and Progression of Huntington's Disease.

AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with HD.

DESIGN: The investigators will include 20 HD mutations carriers and 15 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FDG PET-MR at baseline and after 2 years.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-75 years.
  • Capacity to understand the informed consent form.
  • For HD group: CAG repeat expansion in HTT ≥ 40.
  • Premanifest HD mutation carriers:
  • No clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4.
  • Early manifest HD patients:
  • Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4.
  • UHDRS-TFC score 7 or higher (Shoulson-Fahn stage 1 and 2).

Exclusion criteria

  • neuropsychiatric diseases other than HD
  • major internal medical diseases
  • white matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
  • history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse
  • contraindications for MR
  • pregnancy
  • previous participation in other research studies involving ionizing radiation with >1 mSv in the previous 12 months.

Treatment and study plan

11C-UCB-J PET-CT

Diagnostic Test

Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

18F-FDG PET-MR

Diagnostic Test

Positron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously.

Primary outcomes

  1. Baseline differences in synaptic density.

    Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.

    Baseline differences (%) in (regional) synaptic density between patients and controls.

  2. Baseline correlations between clinical scores and regional synaptic density.

    Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.

    Correlations between clinical scores and regional synaptic density in the patient group at baseline.

  3. Differences in the rate of decline of synaptic density.

    Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

    Differences (%) in the rate of decline of synaptic density between patients and controls.

  4. Correlations between progression of the clinical scores and decline of synaptic density.

    Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

    Correlations between progression of the clinical scores and decline of synaptic density in the patient group, after longitudinal follow up of 2 years.

Secondary outcomes

  1. Baseline differences in cerebral glucose metabolism.

    Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.

    Baseline differences (%) in (regional) glucose metabolism between patients and controls.

  2. Baseline correlations between clinical scores and cerebral glucose metabolism.

    Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

    Correlations between clinical scores and cerebral glucose metabolism in the patient group at baseline.

  3. Differences in the rate of decline of cerebral glucose metabolism.

    Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

    Differences (%) in the rate of decline in cerebral glucose metabolism between patients and controls.

  4. Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.

    Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.

    Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Longitudinal Measurement of Synaptic Density to Monitor Progression of Huntington's Disease.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2021
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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