Actively Recruiting
In Vivo Quantification of Hsp90 in the Human Brain in Healthy Aging and Neurodegeneration Using the Novel PET Radioligand [11C]HSP990
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-02-02
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new radiolabeled molecule called [11C]HSP990 using PET imaging to measure levels of Heat Shock Protein 90 (Hsp90) in the human brain. Hsp90 plays a key role in how brain proteins fold and maintain cell health. The study focuses on healthy volunteers and patients with neurodegenerative diseases including Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis, where protein misfolding is common. This imaging approach aims to support development of drugs targeting Hsp90. The study involves three parts. First, three healthy volunteers will have whole-body PET/CT scans over 120 minutes to study the tracer's distribution and radiation exposure. Next, five young healthy volunteers will undergo 120-minute brain PET/CT scans with blood sampling to analyze how much tracer reaches the brain and is metabolized. Finally, 30 patients with neurodegenerative diseases and 10 healthy controls will have brain PET/CT scans using a simplified protocol to compare regional brain uptake of the tracer between groups. Participants will attend scanning visits lasting about 4 hours each, with some undergoing repeat scans within a week to check measurement reliability. Researchers will assess Hsp90 levels right after each scan and analyze safety, radiation dose, and optimal imaging methods. The study also examines age effects on Hsp90 in healthy brains and differences in patients. Results may help develop new treatments and improve understanding of neurodegeneration. Participation involves imaging, blood sampling, and health assessments with close monitoring throughout the study.
CONDITIONS
Brief Title
Quantification of Hsp90 in the Human Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained prior to any screening procedures
- Use of highly effective birth control methods if applicable
- Male or female subjects aged 18-55 years for Part 1, 18-40 years for Part 2, or 40-70 years for Part 3
- Judged to be in good health based on medical history, physical exam, lab tests, and urinalysis
- No history or current major neurological, internal, or psychiatric disorders
- For subjects under 60 years, a normal MRI scan; for 60 years or older, acceptable white matter lesions with Fazekas score less than 2
- Parkinson's disease patients aged 45-85 years with established diagnosis and Hoehn-Yahr stage I-III
- Alzheimer's disease patients aged 45-85 years with MoCA score under 26 and confirmed diagnosis
- Amyotrophic lateral sclerosis patients aged 20-85 years meeting diagnostic criteria
- Ability to understand study information and provide written consent
You will not qualify if you...
- History of major diseases interfering with study or making participation unfit (e.g., diabetes, heart, liver, kidney disease, cancer)
- Prior or concurrent 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 less than 60 ml/min
- Current or past illicit drug or alcohol abuse
- Contraindications to MRI scanning for relevant parts
- Known hypersensitivity to radiopharmaceutical components
- Claustrophobia or inability to lie still for at least 70 minutes during scanning
- Unwillingness to avoid strenuous physical activity during study period
- Lack of understanding or unwillingness to perform study procedures
- Pregnancy or breastfeeding
- Women of childbearing potential not agreeing to appropriate contraception during and 6 months after study
- Men with partners of childbearing potential not agreeing to condom use during and 90 days after study
- Abnormal Allen test or allergy to lidocaine for parts involving arterial sampling
- Anticoagulant therapy excluding arterial sampling participation
- For Parkinson’s, Alzheimer's, and ALS: neuropsychiatric diseases other than the study condition, major internal comorbidities, high white matter lesion load, alcohol abuse, MR contraindications, and specific ALS motor neuron involvement patterns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several visits over a few weeks depending on cohort assignment
Participants undergo PET/CT brain and whole-body scans using the [11C]HSP990 radiotracer to measure Hsp90 levels in the brain and biodistribution in the body.
1 to 2 scanning visits per participant, each lasting approximately 4 hours
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaam-Brabant, Belgium, 3000
Actively Recruiting
Research Team
K
Koen Van Laere, MD, PhD, DSc
G
Guy Bormans, PhD, DSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here