TB006 for Alzheimer's Disease

No longer recruiting at 9 trial locations

Overseen By TrueBinding, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: TrueBinding, Inc.

Disqualifiers: Psychiatric illness, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 101 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called TB006 to determine its safety and effectiveness for people with Alzheimer's disease. The goal is to understand the drug's behavior in the body and its long-term effects on the disease. Participants may include those who completed a previous study with TB006 or new individuals with Alzheimer's who meet specific criteria. Eligible participants must have a confirmed Alzheimer's diagnosis and be able to walk independently. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer.

Is there any evidence suggesting that TB006 is likely to be safe for humans?

Research has shown that TB006 is well-tolerated by patients in clinical trials. Studies have not found any serious side effects in people with Alzheimer's disease who took TB006. In trials with healthy volunteers, TB006 proved safe, with no drug-related problems reported. This suggests that TB006 is generally safe for humans, based on previous study data. ^{1 2 3 4 5}

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

Researchers are excited about TB006 for Alzheimer's Disease because it offers a unique approach to treatment. Unlike current options like cholinesterase inhibitors and memantine, which generally aim to manage symptoms, TB006 is administered via an intravenous (IV) infusion, potentially allowing for more direct and efficient delivery of the treatment. This new method may offer advantages in targeting the underlying disease mechanisms more effectively. Moreover, the once-every-28-day dosing schedule could improve convenience and adherence for patients and caregivers compared to daily oral medications.

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

Research has shown that TB006, which participants in this trial will receive, may help treat Alzheimer's disease. In earlier studies, almost half of the patients who received TB006 showed improvements in memory and thinking skills. Additionally, 82% of participants experienced a significant drop in their ADAS-Cog12 scores, a test measuring memory and thinking abilities. TB006 is a monoclonal antibody, a type of protein that helps the immune system target harmful substances in the body. These findings suggest that TB006 might improve brain function in people with Alzheimer's. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants or caregiver must understand the purpose and risks of the study and provide signed and dated informed consent

De novo participants referred by the sponsor and meeting specific criteria

I cannot become pregnant.

Exclusion Criteria

I have not had major surgery, significant blood loss, or used alcohol/substances recently.

I have a condition that could lead to memory loss.

Lead-in study participants with intolerable adverse events or important safety risks in Protocol TB006AD2102

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TB006 4000 mg via a 1-hour continuous intravenous (IV) infusion once every 28 days for 101 weeks

101 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Open-label extension

Participants continue to receive TB006 to assess long-term safety and tolerability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• TB006

Trial Overview 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.

How Is the Trial Designed?

Group I: TB006 4000 mg Experimental Treatment 1 Intervention

TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day

Who Is Running the Clinical Trial?

TrueBinding, Inc.

Lead Sponsor

Trials

7

Recruited

440+

Published Research Related to This Trial

In a study of 1332 patients with Alzheimer's disease or other dementias in France, the prevalence of adverse drug reactions (ADRs) was found to be 5.0%, with serious ADRs occurring in 31.9% of cases, highlighting the potential risks associated with medication in this population.

The most common ADRs were gastrointestinal, central nervous system, and psychiatric disorders, with anti-dementia and psychotropic drugs being the most frequently implicated, indicating a need for careful monitoring and prescribing practices in patients with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in patients with Alzheimer's disease and related dementia in France: a national multicentre cross-sectional study. Laroche, ML., Perault-Pochat, MC., Ingrand, I., et al.[2013]

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 constipation (4.3%-4.7%), indicating a consistent profile of side effects among patients taking placebo.

Larger multinational studies showed higher overall discontinuation rates (24.6%-33.0%) compared to smaller studies (8.2%-21.0%), suggesting that study size and geography may influence patient retention and safety outcomes in Alzheimer's trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of Alzheimer's disease populations in Alzheimer's Disease Neuroimaging Initiative and other 18-month studies. Henley, DB., Sundell, KL., Sethuraman, G., et al.[2021]

In a pooled analysis of safety data from 1054 participants in two Phase 3 Alzheimer's disease studies, the overall annualized discontinuation rate was 21.6%, with 8.2% of participants discontinuing due to adverse events, highlighting the challenges of maintaining participants in clinical trials.

Adverse events such as falls, pneumonia, and atrial fibrillation were more common in older participants, indicating that age significantly influences safety outcomes in Alzheimer's disease trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and dropouts in Alzheimer's disease studies: what can we learn? Henley, DB., Sundell, KL., Sethuraman, G., et al.[2015]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10272781/

Alzheimer's disease and neuroinflammation: will new drugs in ... Encouraging results were also observed in clinical endpoints with 82% of 17 patients experiencing a 2.6-point decrease in ADAS-Cog12. In January 2022, the ...

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

TrueBinding reports data from Phase Ib/II Alzheimer's ... An investigational humanised monoclonal antibody, TB006 showed the potential to boost the cognition and functioning of AD patients in ...

4. 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.

5. 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.

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

Understanding TB006 Side Effects: Risks and Precautions TB006 is an experimental drug aimed at slowing or reversing Alzheimer's disease. · Clinical trials have found no serious adverse effects in Alzheimer's patients.

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

TB006 for Alzheimer's Disease · Info for Participants There is no specific safety data available for TB006 in the provided research articles. ... In a review of safety data from five 18-month Alzheimer's disease ...

8. 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.