Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT07380204

Quantification of Hsp90 in the Human Brain

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-02-02

48

Participants Needed

1

Research Sites

169 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study tests the radiolabeled molecule ("tracer"), \[¹¹C\]HSP990, using positron emission tomography (PET) imaging to assess whether it can be used to measure levels of Heat Shock Protein 90 (Hsp90). The protein Hsp90 plays an important role in how proteins in the brain fold into their three-dimensional structure and how this protein helps maintain cellular homeostasis. Since neurodegenerative diseases such as Alzheimer's disease (AD), Parkinson's disease (PD), and amyotrophic lateral sclerosis (ALS) are characterized by disrupted three-dimensional protein folding resulting in protein aggregation, we also aim to measure Hsp90 levels in patients with these conditions. \[¹¹C\]HSP990 is a promising tracer for this purpose and has already been extensively tested in animal models with safe and favorable results. The investigator now aims to evaluate this tracer in the human brain in healthy volunteers as well as in patients with Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis. The investigator expects that Hsp90 protein levels will be present at reduced concentrations in patients, possibly in different brain regions depending on the distribution of the disease-causing proteins associated with these disorders. Since the discovery of the important role of Hsp90 in neurodegenerative diseases, several candidate drugs targeting Hsp90 have been developed in recent years. The imaging method used in this study may support the development of Hsp90-targeting medications by enabling measurement of Hsp90 levels in the brain and assessment of the effects of these drugs.

CONDITIONS

Official Title

Quantification of Hsp90 in the Human Brain

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary written informed consent obtained before screening
  • Use of highly effective birth control methods if applicable
  • Age between 18-55 for Part 1, 18-40 for Part 2, or 40-70 for Part 3 for healthy controls
  • Good health based on medical history, physical exam, lab tests, and urinalysis
  • No current major neurological, internal, or psychiatric disorders
  • Normal structural MRI or acceptable white matter changes if aged 60 or older for Parts 2 and 3
  • For Parkinson's disease: age 45-85, clinically established diagnosis with Hoehn-Yahr stage I-III, previous abnormal DaT scan, able to consent
  • For Alzheimer's disease: age 45-85, MoCA score below 26, probable AD diagnosis with biomarker evidence, able to consent
  • For ALS: age 20-85, meets revised El Escorial and Awaji-Shima criteria, able to consent
Not Eligible

You will not qualify if you...

  • History of major diseases interfering with study or safety (e.g., diabetes, heart, liver, kidney disease, cancer)
  • Prior or current treatments jeopardizing safety or study integrity
  • Participation in other interventional trials with investigational drugs or devices
  • Evidence of cognitive impairment or psychiatric disease
  • Renal impairment with eGFR below 60 ml/min
  • Current or past illicit drug use or alcohol abuse
  • Contraindications for MRI or PET scanning procedures
  • Hypersensitivity to radiopharmaceutical excipients
  • Claustrophobia or inability to lie still for 70 minutes during scans
  • Unwillingness to avoid strenuous physical activities during study
  • Inability or unwillingness to understand or complete study procedures
  • Pregnancy or breastfeeding
  • Women of childbearing potential not agreeing to effective contraception during and 6 months after study
  • Men with partners of childbearing potential not agreeing to use condoms until 90 days after study
  • Abnormal Allen test or allergy to lidocaine for Parts 2 and 3
  • Anticoagulant therapy excluding arterial sampling parts
  • Neuropsychiatric diseases other than cohort condition for Parkinson's and related exclusions for Alzheimer's and ALS
  • ALS patients with only upper or lower motor neuron involvement (primary lateral sclerosis or progressive muscular atrophy)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaam-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

K

Koen Van Laere, MD, PhD, DSc

CONTACT

G

Guy Bormans, PhD, DSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Quantification of Hsp90 in the Human Brain | DecenTrialz