← Back to Search

Monoclonal Antibodies

TB006 for Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by TrueBinding, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 113 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing TB006, a treatment for Alzheimer's disease. It includes people who were part of a previous study or were eligible for it. Researchers want to see how safe TB006 is, how it moves through the body, and its effects on Alzheimer's symptoms over time. T-006, a small-molecule compound derived from tetramethylpyrazine (TMP), has potential for the treatment of neurological diseases.

Who is the study for?
This trial is for adults with Alzheimer's who finished the TB006AD2102 study or could have joined it. They must be able to understand the study, follow visit schedules, and use contraception if needed. New participants should be over 50 years old, weigh at least 50 kg, have a BMI of 18-35 kg/m^2, an MMSE score of 24 or less, and be able to walk.
What is being tested?
The trial tests TB006's safety and effects in Alzheimer's patients over up to 113 weeks. It looks at how the body processes the drug (pharmacokinetics) and its impact on disease markers (pharmacodynamics). Everyone gets TB006 since it’s an open-label extension study.
What are the potential side effects?
Specific side effects aren't listed here but generally include any negative reactions experienced by participants during previous studies with TB006 or might arise from long-term use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 113 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 113 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
Secondary study objectives
Change from Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR SB) score
Change from Baseline in EuroQol 5 Dimension 5-Level quality of life (EQ 5D 5L QoL) total score
Change from Baseline in Mini Mental State Examination (MMSE) score
+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 154 Patients • NCT05074498
14%
Blood urea increased
14%
Thyroid function test abnormal
14%
Pyrexia
14%
Gastroenteritis
14%
Sinus tachycardia
14%
Nausea
14%
Asthenia
14%
Fatigue
14%
COVID-19
14%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Placebo
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
Part 1: Placebo
Part 1: TB006 420 mg qw
Part 2: TB006 1000 mg qw
Part 1: TB006 1000 mg qw

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TB006 4000 mgExperimental Treatment1 Intervention
TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TB006
2021
Completed Phase 2
~160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease often target amyloid plaques, tau proteins, and neuroinflammation. Amyloid-targeting therapies, such as aducanumab, aim to reduce amyloid-beta plaques in the brain, which are believed to contribute to neuronal damage and cognitive decline. Tau protein-targeting treatments focus on preventing the formation of neurofibrillary tangles, another hallmark of AD that disrupts neuronal function. Anti-inflammatory approaches aim to reduce neuroinflammation, which is thought to exacerbate neuronal damage. These mechanisms are crucial as they address the underlying pathophysiological processes of AD, potentially slowing disease progression and improving cognitive function in patients.
Disease modifying strategies for the treatment of Alzheimer's disease targeted at modulating levels of the beta-amyloid peptide.

Find a Location

Who is running the clinical trial?

TrueBinding, Inc.Lead Sponsor
5 Previous Clinical Trials
202 Total Patients Enrolled

Media Library

TB006 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05476783 — Phase 2
Alzheimer's Disease Research Study Groups: TB006 4000 mg
Alzheimer's Disease Clinical Trial 2023: TB006 Highlights & Side Effects. Trial Name: NCT05476783 — Phase 2
TB006 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05476783 — Phase 2
~57 spots leftby Dec 2025