NCT05476783

A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease

A Multi-center Open-label Long Term Extension Study to Assess the Safety of TB006 in Patients Who Have Completed Protocol TB006AD2102 and in De Novo Patients With Alzheimer's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: TrueBinding, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	TB006	Clear to slightly opalescent, sterile solution for injection

Timeline

• Start date: 2022-09-14
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2022-07-27
• Last updated: 2024-12-10

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study