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Clinical Trial Summary

This is an open-label long term extension study for participants with Alzheimer's disease (AD) who have completed Protocol TB006AD2102 (lead-in study) or participants who would have been eligible for the lead-in study but were not enrolled (de novo). The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TB006. The total study duration for each participant will be up to 113 weeks.


Clinical Trial Description

The total study duration for each participant will be up to 113 weeks [This includes 101 weeks (2 years) of dosing and a 12-week safety follow-up period]. The number of participants enrolled from the lead-in study will be 100 to 120 and additionally, up to 50 de novo participants, identified by the sponsor, may be included. A total of approximately 150 to 180 participants will be enrolled. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05476783
Study type Interventional
Source TrueBinding, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 14, 2022
Completion date October 2024

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