CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
TB006 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05074498
NCT05074498Phase 2Completed
CompareCT.gov

A Seamless Phase 1b/2a Double-blind, Randomized, Multiple Dose, Multi-center, Sequential Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of TB006 in Patients With Mild to Severe Alzheimer's Disease

TrueBinding, Inc.·interventional·Posted Oct 12, 2021·Updated Nov 18, 2023

In Brief

A Phase 2 clinical trial evaluating TB006 and Placebo for Alzheimer's Disease. Completed, enrolled 154 participants across 18 sites.

Detailed Summary

Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006 (production of anti-TB006 antibody). Part 2 of this study will be conducted to determine the clinical efficacy of TB006 in participants with mild to severe Alzheimer's Disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 12, 2021
Enrollment StartOct 8, 2021
Primary CompletionOct 13, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.7 years ago

Interventions

TB006drug

intravenous infusion

Placebodrug

intravenous infusion