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New treatment option for Parkinson's Disease (PD)
Official title Quantification of Hsp90 in the Human Brain
ClinicalTrials.gov ID: NCT07380204
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Healthy controls
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per...
- Male or female people, age between 18-55 (Part 1, n = 3), 18-40 (Part II, n = 5) or 40-70 (Part III, 40-55 n = 5, 55-70 n = 5) years old.
- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical...
You likely can't join if
- Healthy controls
- Participant has a history of any major disease that may interfere with the investigations or make the subject unfit for participation according to...
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial .
- Participation in an treatment Trial with an investigational medicinal product (IMP) or device.
- Evidence of cognitive impairment.
- Subject has a history or evidence of psychiatric disease.
See the full eligibility criteria
Who can join
- Healthy controls
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants...
- Male or female people, age between 18-55 (Part 1, n = 3), 18-40 (Part II, n = 5) or 40-70 (Part III, 40-55 n = 5, 55-70 n = 5) years old.
- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.
- No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment (SCL-90).
- (Part II and III only: ) In people \ = 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) Fazekas score \< 2 on the Age-Related White Matter changes scale are acceptable...
- Age 45-85 years.
- Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria and is in Hoehn-Yahr stage I-III in the "on" medication state
- Patient has had a previous abnormal DaT-scan confirming the clinical diagnosis.
- Patient is able to understand the patient information brochure and give written informed consent Alzheimer's disease
- Age 45-85 years.
- MoCA score \< 26
- Patient has a diagnosis of probable AD with evidence of the AD pathophysiological process (amyloid PET scan or CSF determination) according to the consensus criteria [McKahn et al 2011, Alzh Dement].
- Patient is able to understand the patient information brochure and give written informed consent. Amyotrophic lateral sclerosis
- Age 20-85 years.
- people will be recruited at the Neurology department of University Hospitals Leuven and must meet revised El Escorial Criteria and Awaji-Shima criteria for at least possible ALS.
- Patient is able to understand the patient information brochure and give written informed consent.
What rules you out
- Healthy controls
- Participant has a history of any major disease that may interfere with the investigations or make the subject unfit for participation according to the interpretation by the investigator (especially diabetes mellitus...
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial .
- Participation in an treatment Trial with an investigational medicinal product (IMP) or device.
- Evidence of cognitive impairment.
- Subject has a history or evidence of psychiatric disease.
- Subject has renal impairment with eGFR \< 60 ml/min.
- Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
- (Part II and III only: ) Subject has a contra-indication for MRI scanning.
- Subject has a known hypersensitivity to any of the excipients that are present in the radiopharmaceutical preparations or to any of the excipients listed in the IMPD for [11C]HSP990.
- Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures. Subject cannot lie still for at least 70 minutes inside a scanner.
- Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning;
- Subject does not understand the study procedures.
- Subject is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.
- Subject is pregnant (according to Ulti Med hCG urine test) or is breastfeeding.
- Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP...
- Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a...
- Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him/herself.
- (Part II and III only: ) An abnormal Allen test or hypersensitivity/allergy to lidocaine.
- (Part II and III only: ) Anticoagulant therapy is an exclusion criterium for undergoing arterial sampling as part of the study. people that have anticoagulant therapy can participate in the study parts without arterial...
- Neuropsychiatric diseases other than the cohort inclusion condition
- Major internal medical comorbidity, in particular diabetes or heart disease
- Subject has renal impairment with eGFR \< 60 ml/min.
- 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 use
- Contraindications for MR
- Subject has a known hypersensitivity to any of the excipients that are present in the radiopharmaceutical preparations or to any of the excipients listed in the IMPD for [11C]HSP990.
- Subject suffers from claustrophobia or cannot tolerate confinement during PET scanning procedures; subject cannot lie still for 70 minutes inside the scanner.
- Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.
- Subject does not understand the study procedures or does not have a guardian who understands the study procedures.
- Subject (or guardian) is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.
- Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him/herself.
- Subject is pregnant (according to Ulti Med hCG urine test) or breastfeeding.
- Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP\...
- Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a...
- Anticoagulant therapy is an exclusion criterium for undergoing arterial sampling as part of the study. people that have anticoagulant therapy can participate in the study parts without arterial sampling. Alzheimer's...
- cf. Parkinson's Disease exclusion criteria
- Subject has confined upper motor neuron involvement (i.e. primary lateral sclerosis) or confined lower motor neuron involvement (i.e. progressive muscular atrophy).
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaam-Brabant, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaam-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.