TB006 for Alzheimer's Disease

(TB006SAD Trial)

Overseen By Anna Cabral

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: TrueBinding, Inc.

Must not be taking: Maintenance medications

Disqualifiers: Significant disease, Smoking, Alcohol, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new treatment, TB006, developed for Alzheimer's disease. Researchers are examining how different doses affect healthy individuals to ensure safety for future use in Alzheimer's patients. The trial includes two groups: one receives the TB006 treatment, and the other receives a placebo, a harmless substance with no treatment effect. Ideal participants are healthy individuals who have not smoked or used nicotine products in the last three months and do not regularly consume large amounts of alcohol. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications, as the trial excludes anyone receiving maintenance medications on a daily basis.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that TB006, a treatment under study for Alzheimer's disease, appears safe. Most side effects are mild, such as infusion reactions, and they typically resolve quickly. In studies with Alzheimer's patients, some experienced shortness of breath and headaches, but only a few reported these.

Early research also suggests that TB006 generally poses a low risk for serious side effects. In a nearly completed trial with healthy volunteers, no drug-related side effects were reported, indicating participants tolerated it well. Overall, the treatment seems to have a good safety record so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

TB006 is unique because it is administered intravenously, allowing for precise control over dosing and rapid distribution in the body. Researchers are excited about TB006 because it potentially offers a new mechanism of action compared to existing treatments, which might lead to improved outcomes. Unlike the standard treatments that often rely on oral administration, the intravenous delivery of TB006 could provide faster onset of action, making it a promising alternative for treating conditions that require immediate intervention.

What evidence suggests that TB006 might be an effective treatment for Alzheimer's?

Research has shown that TB006, a monoclonal antibody, may help treat Alzheimer's disease. Nearly half of the patients who used TB006 for three months demonstrated improved thinking skills or a slowing of the disease. Some patients noticed improvements after just one month. These results suggest that TB006 could alleviate Alzheimer's symptoms. Although more studies are needed, these findings offer hope for new treatment options. Participants in this trial will receive either TB006 or a placebo to further evaluate its effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

George Haig, PharmD

Principal Investigator

TrueBinding, Inc.

David Walling, MD

Principal Investigator

Collaborative Neuroscience Research

Are You a Good Fit for This Trial?

Inclusion Criteria

Healthy volunteers, male or female 18-55 at the time of informed consent

In good health as determined by the principal investigator Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive).

Chinese subjects are eligible to be included in the study if all of the following criteria apply in addition to the above: Must have been born in China, with 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview; Must have lived no more than 10 years outside of China; Must not have changed their lifestyle or habits significantly, including diet, since leaving China.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of TB006 or placebo administered as an IV infusion over 1 hour

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics, including adverse events and PK parameters, until Day 75

10 weeks

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Sterile saline (Placebo)
• TB006

How Is the Trial Designed?

Group I: TB006 70 mg - 5000 mg IV Experimental Treatment 1 Intervention

TB006 infused intravenously over 1 hour

Group II: Placebo Placebo Group 1 Intervention

0.9% normal saline infused intravenously over 1 hour

Who Is Running the Clinical Trial?

TrueBinding, Inc.

Lead Sponsor

Trials

7

Recruited

440+

Citations

1. alzheimersnewstoday.com alzheimersnewstoday.com/news/signs-alzheimers-reversed-eased-after-3-months-tb006/

Signs of Alzheimer's reversed, eased after 3 months of TB006 Nearly half the Alzheimer's disease patients treated with TrueBinding's investigational therapy TB006 showed cognitive improvement signs.

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/truebinding-alzheimers-treatment-trial/

TrueBinding reports data from Phase Ib/II Alzheimer's ... According to the findings, one month of treatment with TB006 showed improvements. In the intent-to-treat (ITT) population, a treatment ...

3. truebinding.com truebinding.com/news

News — TrueBinding Nearly half of the patients treated with TB006 for three months or longer showed signs of disease reversal or cognitive improvement. The study builds upon ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05476783

NCT05476783 | A Long Term Extension Study to Assess ... The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TB006.

5. firstwordpharma.com firstwordpharma.com/story/5721294

Open-Label Extension Study for Alzheimer's Treatment ... The one-month treatment of Alzheimer's Disease with TB006 in the blinded phase 2a trial yielded strong clinical data pointing to a trend of disease reversal.

6. universalneurocare.com universalneurocare.com/tb006-side-effects/

Understanding TB006 Side Effects: Risks and Precautions A: Most side effects associated with TB006 are mild, such as infusion reactions. They are generally short-lived and usually subside shortly after the infusion ...

7. withpower.com withpower.com/trial/phase-2-alzheimer-disease-7-2022-c2cbc

TB006 for Alzheimer's Disease · Info for Participants In a review of safety data from five 18-month Alzheimer's disease trials, common adverse events included dyspnea (5.3%-5.8%), headache (4.0%-5.5%), and ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/98/NCT05074498/Prot_000.pdf

CLINICAL PROTOCOL The preclinical data on TB006 to date suggests a wide margin of safety and minimal risk of adverse effects. The risks associated with study ...

9. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.060393

Potential Reversal of Alzheimer's Disease pathology by ... Clinically, TB006 has shown a superior safety profile without any drug-related adverse events in a nearly finished healthy volunteer trial.