A non-therapeutic feasibility study to evaluate the kinetics and test-retest repeatability and reproducibility of the radioligand [11C]-UCB-J for imaging synaptic density in healthy subjects and mild-to-moderate Alzheimer*s Disease subjects

A non-therapeutic feasibility study to evaluate the kinetics and test-retest repeatability and reproducibility of the radioligand [11C]-UCB-J for imaging synaptic density in healthy subjects and mild-to-moderate Alzheimer*s Disease subjects - 170439 - RDN-NI-001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48549

Enrollment

Registered

2018-06-06

Start date

2018-08-02

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease Alzheimer dementia

Interventions

Injection with [11C]-UCB-J .

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1: Healthy male or female age 50 * 80 years old, inclusive, at the time of informed consent.;Group 2: Adult males or females age 50 * 80 years old, inclusive, at the time of informed consent. Confirmed diagnosis of mild-to-moderate AD.

Exclusion criteria

Exclusion criteria: History or current evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (with the exception of AD in Group 2), psychiatric, renal, or other major disease, as determined by the Investigator.

Design outcomes

Primary

Measure	Time frame
[11C]-UCB-J Kinetics Parameters PET Parameters Safety and Tolerability Parameters	—

Secondary

Measure	Time frame
Biomarker Parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)