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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
Females must be of non-childbearing potential
Participants must be literate and capable of reading, writing, and communicating effectively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, and weeks 1, 5, 9, 13, 17, 21, 25, 45, 73, 101 and 113
Awards & highlights

Study Summary

This trial is for people with Alzheimer's who have completed another study, or who weren't able to be in the other study. It will last 113 weeks and researchers will be looking at how safe and well tolerated the study drug is, as well as how it affects the body.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I cannot become pregnant.
Select...
I can read, write, and communicate effectively.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, and weeks 1, 5, 9, 13, 17, 21, 25, 45, 73, 101 and 113
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, and weeks 1, 5, 9, 13, 17, 21, 25, 45, 73, 101 and 113 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
Number of Participants with Anti-TB006 Antibodies
Number of Participants with Clinically Significant 12-Lead electrocardiogram Findings
+7 more
Secondary outcome measures
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
+5 more

Side effects data

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

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What perils does TB006 pose to humans?

"Due to the experimental nature of TB006, our team at Power rated its safety a 2 as there is only evidence supporting its safety and not efficacy."

Answered by AI

Is it still possible to join this trial and participate?

"According to clinicaltrials.gov, this medical trial has ended its recruitment process as of October 19th 2022. Initially posted on September 14th 2022, the study is no longer seeking new candidates; however, there are an abundance of other trials that remain open for enrollment at present."

Answered by AI

In what locations is the trial being conducted?

"At present, 10 diverse sites across the country are running this medical trial. These locations include Maitland, West Palm Beach and Lady Lake as well as other nearby cities. To limit travel demands when enrolling, it is wise to select a location closest to you."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease
2022. "A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05476783.
~37 spots leftby Oct 2024
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