Synaptic density and tau pathology in Alzheimer’s disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

10 Dec 2024 → ongoing

Decision date (initial)

2024-12-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMw

External identifiers

EU CT number

2024-517636-22-00

EudraCT number

2020-002511-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Aim to quantify brain regional [18F]SynVesT-1 uptake (synaptic density) and [18F]flortaucipir uptake and their association

Secondary objectives 1

1. To investigate the associations between [18F]Flortaucipir (tau) binding and [18F]SynVesT-1 (synaptic density) binding

Conditions and MedDRA coding

Alzheimer's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - At least 50 years of age; - Biomarker evidence (CSF or PET) for the presence of Aβ pathology. - Subjects must, in the opinion of the attending neurologist be able to tolerate study procedures and be competent to make a well-informed decision to participate in this study; - Signed informed consent for Amsterdam Dementia Cohort 2016.061);

Exclusion criteria 1

1. - Has contra indications for MRI scanning and therefore has and cannot receive brain MRI; - 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 orally confirm not to be pregnant or breast feeding at screening; - Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the Principal Investigator; - Has ever participated in an experimental study with a tau, amyloid or synapse targeting agent, unless it can be documented that the subject received only placebo during the course of the trial; - 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 exceeds 11.3 mSv for females and 15.3 mSv for males. - Is a member of the study team, an employee of the department of Radiology and Nuclear medicine or the department of Neurology of the Amsterdam UMC, or is related to an employee of department of Radiology and Nuclear medicine or the department of Neurology of the Amsterdam UMC. The following medications during the study and 4 weeks prior to [18F]SynVesT-1 PET: o Use of anticonvulsant medications; o Other medications that, in the opinion of the Investigator, may interfere with the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Quantification of brain regional [18F]SynVesT-1 uptake (synaptic density) and regional [ 18F]flortaucipir uptake (tau)

Secondary endpoints 1

1. association between [18F]Flortaucipir (tau) binding and [18F]SynVesT-1 (synaptic density) binding

Investigational products

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

Test 2

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

Roos Rikken

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Roos Rikken

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 5 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