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In Vivo Quantification of Hsp90 in the Human Brain in Healthy Aging and Neurodegeneration Using the Novel PET Radioligand [11C]HSP990
Sponsor study identifier
Secondary identifiers
CTIS
NIH
interventional
48
1 country
1
Study Start
September 4, 2024
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2024
Actual (reported)January 5, 2026
Actual (reported)February 2, 2026
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Quantification of HSP90 in the human brain
To quantify and compare Hsp90 levels in vivo in the human brain of healthy volunteers and patients with neurodegenerative disorders using the novel PET radioligand \[11C\]HSP990.
This will be assessed right after each scan in cohort 2 and 3. (Estimated visit lenght in cohort 2 will be 4 hours for each scanning procedure. In cohort 3 this will be optimized based on the results of cohort 2.)
To assess the safety and clinical tolerance of [11C]HSP990 administration.
From enrollment until 1 week after completion of scan.
To determine the radiation dosimetry of [11C]HSP990 in humans.
This will be assessed right after each scan in cohort 1. (Estimated lenght of the scanning visit is 4 hours.)
In this part of the study, three healthy volunteers (2 male / 1 female, aged 18-55 years) will undergo consecutive whole-body PET/CT scans over a period of 120 minutes to measure the biodistribution in the body and the radiation exposure of \[¹¹C\]HSP990 in humans.
In this part of the study, five young healthy volunteers (male/female, aged 18-40 years) will undergo a PET/CT brain scan with a total duration of 120 minutes (70 minutes of scanning - 20 minutes break - 30 minutes scanning). During the scan, the amount of tracer reaching the brain via the bloodstream will be determined using blood samples taken from an artery. In addition, the breakdown of the tracer by the liver and the formation of by-products ("metabolite" analysis) will be measured in order to determine how much intact tracer reaches the brain. This is necessary to quantify the amount of Hsp90 protein in the brain based on the tracer concentration. If possible, a simplified approach will be developed to minimize the physical burden of the study for participants in Part 3 of the study. All five volunteers will also undergo a retest scan within an interval of one week in order to determine the precision (test-retest reliability).
120 minute whole body PET/CT scan with \[11C\]HSP990 radiotracer
2 120-minute brain PET scan with \[11C\]HSP990 radiotracer
UZ Leuven
Leuven, Vlaam-Brabant, 3000, Belgium
Koen Van Laere
KU Leuven
First Submitted
January 5, 2026
First Posted
February 2, 2026
Study Start
September 4, 2024
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To determine the optimal brain tracer kinetic modelling approach and test-retest variation (TRV) for [11C]HSP990 brain PET in humans.
This will be assessed right after each scan in cohort 2. (Estimated lenght of each scanning visit is 4 hours.)
To determine the optimal imaging protocol for quantifying Hsp90 levels in human brain using [11C]HSP990 and develop if possible, a simplified imaging protocol or patient comfort.
This will be assessed right after each scan in cohort 2. (Estimated lenght of the scanning visit is 4 hours.)
To assess age-dependency of Hsp90 levels in healthy human brain using [11C]HSP990
This will be assessed right after each scan in cohort 2 and 3. (Estimated visit lenght in cohort 2 will be 4 hours for each scanning procedure. In cohort 3 this will be optimized based on the results of cohort 2.)
In this part of the study, 30 patients (10 with Parkinson's disease \[PD\], 10 with Alzheimer's disease \[AD\], and 10 with amyotrophic lateral sclerosis \[ALS\]) and 10 healthy controls will undergo a dynamic simultaneous PET/CT brain scan, using the least invasive protocol as established in Part 2, to investigate whether the (regional) brain uptake of the tracer \[¹¹C\]HSP990 differs between healthy aging and patients with neurodegenerative disease.
Simplified quantitative \[11C\]HSP990 PET scan as will be determined in part 2.
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Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 2, 2026
Record last verified: 2026-01
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