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SV2A PET Imaging in Alzheimer's Disease
NCT04871074Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2018
- Primary completion
- Oct 2023
- Countries
- 1
- Sponsor
- University of Wisconsin–Madison
- Modality
- Small Molecules
- Drugs
- 11C-UCB-J
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 2, open-label, single-arm trial of 11C-UCB-J in Alzheimer's disease (AD), sponsored by University of Wisconsin–Madison. Primary endpoints: ROC AUCs (MCI/AD vs Cognitively Unimpaired (CU)) for Medial Temporal Lobe (MTL) UCB-J Distribution Volume Ratio (DVR) and Hippocampal Volume, ROC AUCs (MCI/AD vs CU) for MTL UCB-J and Hippocampal Cingulum Neurite Density Index and 5 more. Started Nov 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Cognitively Impaired plus Cognitive Unimpaired Participants
Participants undergo baseline and 2-year follow-up PET imaging with UCB-J and MRI scans.
03
Who it enrols
Adults aged 50-89 who are either cognitively unimpaired or have mild dementia/amnestic MCI, willing to undergo PET and MRI scans, excluding those with unstable medical conditions, major psychiatric disorders, or taking Levetiracetam.
04
Endpoints
Primary
ROC AUCs (MCI/AD vs Cognitively Unimpaired (CU)) for Medial Temporal Lobe (MTL) UCB-J Distribution Volume Ratio (DVR) and Hippocampal Volume
ROC AUCs (MCI/AD vs CU) for MTL UCB-J and Hippocampal Cingulum Neurite Density Index
Annual Rate of Change in UCB-J DVR
Baseline Diagnosis Group Differences in Annual Rate of Change in UCB-J DVR
Amyloid Positivity Status Differences in Annual Rate of Change in UCB-J DVR
Secondary
Difference Between ROC AUCs (MCI/AD vs CU) for Medial Temporal Lobe (MTL) UCB-J Distribution Volume Ratio (DVR) and Cerebrospinal Fluid (CSF) Neurofilament Light Chain Protein (NfL)
Difference Between ROC AUCs (MCI/AD vs CU) for MTL UCB-J DVR and Cerebrospinal Fluid (CSF) Total-tau (T-tau)
Difference Between ROC AUCs (MCI/AD vs CU) for MTL UCB-J and CSF Neurogranin
Sex Differences in Annual Rate of Change in UCB-J DVR
Age Differences in Annual Rate of Change in UCB-J DVR
APOE4 Allele Status Differences in Annual Rate of Change in UCB-J DVR
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