TAP-TA

Phase 1

• Conditions: Mild cognitive impairment and dementia; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-505430-10-00
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified