Clinical trial • Phase IV • Neurology

Flortaucipir (18F) for Preclinical Alzheimer's disease | Healthy volunteers

Phase IV trial of Flortaucipir (18F) for Preclinical Alzheimer's disease | Healthy volunteers. 80 participants.

Overview

Phase IV trial across 1 site in Netherlands.

Recruits 80 No vulnerable population selected. Informed consent form available (L1_SIS and ICF_TauTwin)..

Vulnerable Population: No vulnerable population selected. Informed consent form available (L1_SIS and ICF_TauTwin).

{"criterion_text":"- In order to be eligible for participation in this study, a subject must be older than 60 years, have received an [18F]flutemetamol amyloid PET scan and/or have a known amyloid status obtained from CSF."}

{"criterion_text":"- A potential subject who meets any of the following criteria will be excluded from participation in this study if he or she: 1. Has contra indications for MRI scanning and therefore has not received brain MRI;"}
{"criterion_text":"- 2. Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan; Tau PET imaging in cognitively normal elderly subjects: A twin approach Version number 9, date: 28‐05‐2024 17"}
{"criterion_text":"- 3. Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the Principal Investigator or Co‐Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc.;"}
{"criterion_text":"- 4. Has ever participated in an experimental study with a tau agent, unless it can be documented that the subject received only placebo during the course of the trial;"}
{"criterion_text":"- 5. Has been injected with a previously administered radiopharmaceutical within 6 terminal half‐ lives or when total yearly radiation exposure exceeds 16.1 mSv for female and 22.4 mSv for male participants[26]."}
{"criterion_text":"- 6. Has a history of severe traumatic brain injury (TBI)"}

{"endpoint_text":"- 1. To investigate the effect of amyloid status(positive versus negative) on (longitudinal) [18F]AV‐ 1451 accumulation in cognitively normal individuals.\n- 2. To investigate the contribution of genetic factors and non‐genetic factors to (longitudinal) tau accumulation and its interaction with amyloid accumulation","definition_or_measurement_approach":"[18F]flortaucipir - PET will be used to measure brain tau accumulation; comparison by amyloid status (positive versus negative) and assessment of genetic and non-genetic contributions to longitudinal tau accumulation."}

Planned Sample Size: 80
Recruitment Window Months: 76
Consent Approach: Informed consent required; Subject information and informed consent form available (L1_SIS and ICF_TauTwin). Participants are adults >60 years and provide their own consent. No assent or proxy consent procedures are described in the provided record. Contact for consent/information: Anouk den Braber (a.denbraber@amsterdamumc.nl).

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