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Monoclonal Antibodies

TB006 for Alzheimer's Disease (TB006SAD Trial)

Phase 1
Waitlist Available
Led By David Walling, MD
Research Sponsored by TrueBinding, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day1-day 75
Awards & highlights

TB006SAD Trial Summary

This trial will study the safety and effectiveness of a new Alzheimer's drug.

TB006SAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1-day 75
This trial's timeline: 3 weeks for screening, Varies for treatment, and day1-day 75 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo
To determine the MTD of single doses of TB006 in healthy adult subjects
To determine the single-dose PK profile of TB006 in healthy adult subjects
Secondary outcome measures
Anti-TB006 antibodies
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29
+7 more

Side effects data

From 2022 Phase 1 & 2 trial • 154 Patients • NCT05074498
14%
Asthenia
14%
Fatigue
14%
COVID-19
14%
Thyroid function test abnormal
14%
Sinus tachycardia
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

TB006SAD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TB006 70 mg - 5000 mg IVExperimental Treatment1 Intervention
TB006 infused intravenously over 1 hour
Group II: PlaceboPlacebo Group1 Intervention
0.9% normal saline infused intravenously over 1 hour
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TB006
2021
Completed Phase 2
~160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TrueBinding, Inc.Lead Sponsor
5 Previous Clinical Trials
334 Total Patients Enrolled
George Haig, PharmDStudy DirectorTrueBinding, Inc.
5 Previous Clinical Trials
1,278 Total Patients Enrolled
David Walling, MDPrincipal InvestigatorCollaborative Neuroscience Research
1 Previous Clinical Trials
65 Total Patients Enrolled

Frequently Asked Questions

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

Does the protocol for this medical research encompass individuals of 20 years and over?

"According to the entry requirements, only individuals between 18 and 55 years of age are eligible for this trial. Meanwhile, 23 studies cater to minors below 18 while 536 trials accommodate those 65 or older."

Answered by AI

Is it possible for me to register as a participant in this research?

"This particular study is enrolling 48 Chinese-born individuals between 18 and 55 with a diagnosis of Alzheimer's. To qualify, they must have both biological parents and all four grandparents born in China; furthermore, the participant cannot have lived outside of China for more than 10 years nor made drastic changes to their lifestyle or diet since leaving."

Answered by AI

Is this experiment actively seeking volunteers?

"Clinicaltrials.gov suggests that, as of 6/3/2021, this clinical trial is actively seeking participants. The original posting for the study was on June 1st 2021."

Answered by AI

What are the ultimate goals of this trial?

"The primary endpoint of this study, observed over the course of 75 days, is to establish a Maximum Tolerated Dose (MTD) for TB006. Secondary outcomes include measuring various pharmacokinetic parameters such as Concentration in Cerebrospinal Fluid (CSF), Area under the Curve from time zero until infinity (AUC D0-∞), and Total Clearance (CL)."

Answered by AI

How many patients have been enrolled in this clinical trial thus far?

"Affirmative. According to the clinicaltrials.gov site, this study is actively recruiting participants. It was initially published on June 1st 2021 and last revised on June 3rd 2021; 48 individuals must be enrolled from a single medical centre."

Answered by AI

To what extent has TB006 been endorsed by the Food and Drug Administration?

"The safety profile of TB006 has been assigned a score of 1, as it is only in the earliest stages of clinical research and lacks robust evidence for its efficacy and safety."

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

Why did patients apply to this trial?

I've tried other trials but wasn't taken in.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects
2021. "Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04920786.
~13 spots leftby Apr 2025
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