drugset / Trial / NCT04871074

The Synapse Project

NCT04871074 ↗

NaSingle-groupOpen-labelDiagnostic

Summary

The overarching goal of this project is to use \[C-11\]UCB-J to obtain spatial information on neuronal synapse abundance and inform Alzheimer's disease (AD) progression. The investigators propose to collect longitudinal amyloid, tau, and Synaptic vesicle glycoprotein 2A (SV2A) positron emission tomography (PET) in participants in the Wisconsin Alzheimer's Disease Research Center (ADRC) and Wisconsin Registry for Alzheimer's Prevention (WRAP) across the clinical stages of AD, including cognitively unimpaired biomarker negative, unimpaired biomarker positive, mild cognitive impairment (MCI), and dementia due to AD.

Timeline

Start
2018-11-18
Primary completion
2023-10-17
Completion
2025-05-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Medial Temporal Lobe UCB-J vs Hippocampal Volume; p = .74; DeLong's Test NCT04871074 ↗

registry analysis (superiority test); Medial Temporal Lobe UCB-J vs Hippocampal Cingulum NDI; p = .66; DeLong's Test NCT04871074 ↗

registry analysis (superiority test); All Participants; p = .135; Mixed Models Analysis NCT04871074 ↗

registry analysis (superiority test); Cognitively Unimpaired; p = .39; Mixed Models Analysis NCT04871074 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject APP-311 Diagnostic / imaging agent — —

Indications