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NeuroPET GBG 001 - Mapping pathogenic processes associated with the development of neurodegenerative disorders using novel neuroimaging modalities
EU CTIS ID: 2024-513499-16-00
What this study is testing
To establish and validate the use of tau PET for the early identification of subjects at risk of developing a neurodegenerative disease and for the mapping of tau pathology over different disease stages.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent form
- ≥18 years old
- For inclusion in this study the investigator must confirm that the patient is able to understand the information relevant to the decision to participate in the study, appreciate the situation in terms of the treatment and research options and their likely outcomes, and weight the potential risks and benefits of participation in order to come to a decision and communicate the decision.Participants enrolled from SweDOWN study can participate with consent from caregiver.
- Be included in one of the following studies:H75, subjects born in 1944, see Appendix A.1. H70 Clinical Study, see Appendix B. Epilepsy Study, see Appendix C. Biologiska prediktorer för minne (BioMin) Study, see Appendix D. SWEDOWN study, see Appendix E.
- Speak and understand Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.
- Fertile women willing to use a highly effective contraception during a period of 90 days after each administration. Such methods include: a) Combined ( estrogen and progestogen containing ) hormonal contraception associated with inhibition of ovalution. b) Progestogen-only hormonal contraception associated with inhibition of ovulation c) lntrauterine device (IUD) d)lntrauterine hormone-releasing system ( IUS)
You likely can't join if
- Person who do not have full decision-making skills. Participants enrolled from SweDOWN-study can participate with consent from caregiver.
- Exclusion criteria for Lumbar Puncture; 1.Treatment with anticoagulants. 2. Local infection lumbar, skin or soft parts. 3.lncreased intracranial pressure (headache, papilledema)
- Significant unstable systemic illness, or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse
- Significant neurological or psychiatric illness.
- Refusing lumbar puncture, MRI or PET.
See the full eligibility criteria
Who can join
- Signed informed consent form
- ≥18 years old
- For inclusion in this study the investigator must confirm that the patient is able to understand the information relevant to the decision to participate in the study, appreciate the situation in terms of the treatment and research options and their likely outcomes, and weight the potential risks and benefits of participation in order to come to a decision and communicate the decision.Participants enrolled from SweDOWN study can participate with consent from caregiver.
- Be included in one of the following studies:H75, subjects born in 1944, see Appendix A.1. H70 Clinical Study, see Appendix B. Epilepsy Study, see Appendix C. Biologiska prediktorer för minne (BioMin) Study, see Appendix D. SWEDOWN study, see Appendix E.
- Speak and understand Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.
- Fertile women willing to use a highly effective contraception during a period of 90 days after each administration. Such methods include: a) Combined ( estrogen and progestogen containing ) hormonal contraception associated with inhibition of ovalution. b) Progestogen-only hormonal contraception associated with inhibition of ovulation c) lntrauterine device (IUD) d)lntrauterine hormone-releasing system ( IUS)
- Male with female reproductive partners to use contraceptives, condoms, at least 90 days after each administration unless the female fertile partner uses highly effective contraceptive drugs during this time.
What rules you out
- Person who do not have full decision-making skills. Participants enrolled from SweDOWN-study can participate with consent from caregiver.
- Exclusion criteria for Lumbar Puncture; 1.Treatment with anticoagulants. 2. Local infection lumbar, skin or soft parts. 3.lncreased intracranial pressure (headache, papilledema)
- Significant unstable systemic illness, or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Current significant alcohol or substance misuse
- Significant neurological or psychiatric illness.
- Refusing lumbar puncture, MRI or PET.
- Pacemaker or other implanted metallic objects incompatible with MRI investigation.
- Claustrophobia
- Female who is pregnant, breast feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.
- Positive result of urine dip stick pregnency test taken before each administration of PET-ligand.(At baseline, follow up 2 year and 4 year)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.