Tau PET imaging in cognitively normal elderly subjects: A twin approach

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Healthy volunteers

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

2 Dec 2024 → ongoing

Decision date (initial)

2024-12-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517634-17-01

EudraCT number

2018-004466-34

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The main objectives are to 1) investigate the relation between tau and amyloid accumulation in cognitively normal individuals, 2) test the contribution of genetic and non‐genetic factors on (longitudinal) tau accumulation in twins, and 3) test the relation of (longitudinal) tau accumulation with other AD‐markers collected in the PreclinAD study.

Conditions and MedDRA coding

Healthy controls (investigating preclinical Alzheimer's Disease)

Regulatory references

Plan to share IPD

Yes

IPD plan description

After completion of recruitment and publication of the main analyses proposed in the application, pseudonymized data will be available for bona fide researchers through the AUMC, where third parties can send a data access request proposal for data-sharing to the PI of the study. Data sharing will be performed under a data transfer agreement (DTA). The final format of the dataset to be shared will be an encrypted csv file with the main outcomes of the study for each participant.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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; 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 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.; 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; 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]. 6. Has a history of severe traumatic brain injury (TBI)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. To investigate the effect of amyloid status(positive versus negative) on (longitudinal) [18F]AV‐ 1451 accumulation in cognitively normal individuals. 2. To investigate the contribution of genetic factors and non‐genetic factors to (longitudinal) tau accumulation and its interaction with amyloid accumulation

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Anouk den Braber

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Anouk den Braber

Locations

1 EU/EEA country · 1 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 3 files

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

Application history

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