TB006 for Alzheimer's Disease

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

180 Participants Needed

Trial Summary

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 TB006 safe for humans?

There is no specific safety data available for TB006 in the provided research articles. ^{1 2 3 4 5}

How is the drug TB006 different from other Alzheimer's treatments?

The drug TB006 is unique because it may target the TRAIL pathway, which is specifically expressed in the brains of Alzheimer's patients and absent in non-demented individuals, potentially offering a novel approach compared to traditional treatments that focus on amyloid or tau proteins. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adverse events and dropouts in Alzheimer's disease studies: what can we learn? [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Safety profile of Alzheimer's disease populations in Alzheimer's Disease Neuroimaging Initiative and other 18-month studies. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Tau-targeting antisense oligonucleotide MAPTRx in mild Alzheimer's disease: a phase 1b, randomized, placebo-controlled trial. [2023]

4. England 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. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Risk factors associated with beta-amyloid(1-42) immunotherapy in preimmunization gene expression patterns of blood cells. [2015]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The pulse of drug development for Alzheimer's disease. [2019]

7. England pubmed.ncbi.nlm.nih.gov

TRAIL is expressed in the brain cells of Alzheimer's disease patients. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Antibody-functionalized polymer nanoparticle leading to memory recovery in Alzheimer's disease-like transgenic mouse model. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Tau Trials for Alzheimer's Disease: A Report from the EU/US/CTAD Task Force. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The amyloid hypothesis of Alzheimer's disease at 25 years. [2023]