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TERMINATED
NCT05476783
PHASE2

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

Sponsor: TrueBinding, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2022-09-15

Completion Date

2023-11-17

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DRUG

TB006

Clear to slightly opalescent, sterile solution for injection

Locations (13)

Clinical Trial Site

San Diego, California, United States

Clinical Trial Site

Delray Beach, Florida, United States

Clinical Trial Site

Lady Lake, Florida, United States

Clinical Trial Site

Maitland, Florida, United States

Clinical Trial Site

Miami, Florida, United States

Clinical Trial Site

Miami, Florida, United States

Clinical Trial Site

Miami, Florida, United States

Clinical Trial Site

West Palm Beach, Florida, United States

Clinical Trial Site

Winter Park, Florida, United States

Clinical Trial Site

Winter Park, Florida, United States

Clinical Trial Site

Decatur, Georgia, United States

Clinical Trial Site

Matthews, North Carolina, United States

Clinical Trial Site

Fairfax, Virginia, United States