Synaptic density and tau pathology in Alzheimer's disease

Phase 2

Recruiting

• Conditions: Alzheimer's disease; 10012272; dementia; 10042258

• Registration Number: NL-OMON52558
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- At least 50 years of age;
- Biomarker evidence (CSF or PET) for the presence of Aβ pathology.
- Subjects must, in the opinion of the principal investigator/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

- 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;
- 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;
- 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;
- 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 [11C]UCB-J
PET:
o Use of anticonvulsant medications;
o Other medications that, in the opinion of the Investigator, may interfere
with the study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main parameters include the quantification of regional [11C]UCB-J (synaptic<br /><br>density) uptake, regional [18F]flortaucipir (tau) uptake, and regional<br /><br>[18F]florbetapir (A&beta;) uptake in AD. The main endpoint includes the associations<br /><br>of (spatial) [11C]UCB-J with regional [18F]flortaucipir and [18F]florbetapir. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the association of (spatial) [11C]UCB-J,<br /><br>[18F]flortaucipir and [18F]florbetapir to neuropsychological performance based<br /><br>on test scores.</p><br>