Tap-Tau

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

10 Oct 2024 → ongoing

Decision date (initial)

2023-12-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 1

1. To compare the diagnostic performance of tau PET against (combinations of) less expensive and more accessible diagnostic tools

Conditions and MedDRA coding

Mild cognitive impairment and dementia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients 50 years or older
2. 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
3. Completed routine work-up including at least basic cognitive screening tests and MRI scanning with a 3DT1 sequence
4. 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.
5. 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

Exclusion criteria 8

1. 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).
2. 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
3. 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)
4. 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)
5. Has ever been treated with an anti-amyloid drug or tau agent (only for tau PET participants)
6. 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
7. 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)
8. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Pre- vs. post-tau PET change in diagnosis (diagnostic categories: AD, non-AD with specification of suspected underlying pathology, mixed AD/non-AD pathology) and comparison with a control group after a year
2. Pre- vs. post-tau PET change in confidence of the clinician in the etiological diagnosis (continuous scale ranging from 0-100%, baseline <85% required) and comparison with a control group after a year.
3. Pre- vs. post-tau PET change in patient management (increase or reduction in ancillary investigations, initiation or withdrawal of medication, initiation or withdrawal of care; we will also assess whether it would influence hypothetical prescription of disease modifying treatment of AD) and comparison with a control group after a year.
4. Pre- vs. post-tau PET change in patient wellbeing (measures of anxiety and uncertainty) and behavioural intentions and post-tau PET perceptions, experiences and understanding of tau PET.

Secondary endpoints 1

1. Performance of tau PET compared to novel blood-based biomarkers and artificial intelligence (AI) based classifiers.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

Marie Vermeiren

Public contact point

Organisation

Amsterdam UMC

Contact name

Marie Vermeiren

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications