BridgeMD
TAP-TAU
EU CTIS ID: 2023-505430-10-00
What this study is testing
To assess the value of tau PET as a diagnostic tool in clinical practice in order to improve diagnostic accuracy, patient management and patient wellbeing.
- Phase II and Phase III (Integrated)
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
- Patients 50 years or older
- Prodromal (i.e. MCI) stage, in which individuals have subjective and/or objective cognitive impairment and a CDR score of 0.5 or mild dementia stage, in which individuals have a CDR score of 1
- Completed routine work-up including at least basic cognitive screening tests and MRI scanning with a 3DT1 sequence
- After routine dementia screening, there is substantial diagnostic uncertainty (<85%) due to i) suspicion of mixed pathology, ii) presence of an atypical clinical presentation, and/or iii) conflicting/inconclusive information from other diagnostic tests like MRI or CSF. AD is in the differential diagnosis.
- Subjects must, in the opinion of the attending neurologist be able to tolerate study procedures (only for the tau PET participants) and be competent to make a well-informed decision to participate in this study
You likely can't join if
- Cognitively normal (defined as no objective cognitive deficits at neuropsychological testing and a Clinical Dementia rating scale (CDR) score of 0) or advanced dementia stage (defined as CDR > 1).
- Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with the clinical presentation and/or interpretation of PET scan
- Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must confirm not to be pregnant or breast feeding at screening; (only for tau PET participants)
- Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the locally appointed coordinating researcher (only for tau PET participants)
- Has ever been treated with an anti-amyloid drug or tau agent (only for tau PET participants)
- History of any clinically significant cardiovascular, endocrinology, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (with the exception of AD), psychiatric, renal or other major disease, as determined by the principal investigator
See the full eligibility criteria
Who can join
- Patients 50 years or older
- Prodromal (i.e. MCI) stage, in which individuals have subjective and/or objective cognitive impairment and a CDR score of 0.5 or mild dementia stage, in which individuals have a CDR score of 1
- Completed routine work-up including at least basic cognitive screening tests and MRI scanning with a 3DT1 sequence
- After routine dementia screening, there is substantial diagnostic uncertainty (<85%) due to i) suspicion of mixed pathology, ii) presence of an atypical clinical presentation, and/or iii) conflicting/inconclusive information from other diagnostic tests like MRI or CSF. AD is in the differential diagnosis.
- Subjects must, in the opinion of the attending neurologist be able to tolerate study procedures (only for the tau PET participants) and be competent to make a well-informed decision to participate in this study
What rules you out
- Cognitively normal (defined as no objective cognitive deficits at neuropsychological testing and a Clinical Dementia rating scale (CDR) score of 0) or advanced dementia stage (defined as CDR > 1).
- Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with the clinical presentation and/or interpretation of PET scan
- Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must confirm not to be pregnant or breast feeding at screening; (only for tau PET participants)
- Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the locally appointed coordinating researcher (only for tau PET participants)
- Has ever been treated with an anti-amyloid drug or tau agent (only for tau PET participants)
- History of any clinically significant cardiovascular, endocrinology, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (with the exception of AD), psychiatric, renal or other major disease, as determined by the principal investigator
- Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives or when total yearly radiation exposure for research exceeds 11.3 mSv for females and 15.3 mSv for males. (only for tau PET participants)
- Is a member of the study team, an employee of the department of Radiology and Nuclear medicine or the department of Neurology in any of the sites or is related to an employee of the department of Radiology and Nuclear medicine or the department of Neurology in any of the sites.
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. 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.