tb006-iv-infusion

TB006 Alzheimer Infusion

Discover the transformative benefits of TB006 for Alzheimers.

Treatment Time:

Up to 60 minutes.

Frequency:

Monthly (3 month minimum)

Category:

TB006

TB006 is an experimental drug used in clinical trails that targets a protein involved in brain inflammation, a process associated with Alzheimer’s disease. This research study will evaluate the safety and effects of TB006 in older adults with mild to severe Alzheimer’s disease. Researchers will measure changes in cognitive function, study drug concentration in the blood and cerebral spinal fluid, and levels of antibodies for up to three months.

Patient Inclusion Criteria

  • Greater than 55 years of age

  • Actual or estimated MMSE test score between 6 to 24, inclusive

    • Conducted in-person, within last 3 months

  • Has a serious or immediately life-threatening condition, for example…

  • Failed at least one dementia medication (e.g. Aricept, Exelon, Namenda…)

    • This criterion is waived if no available first-line treatment (Frontotemporal dementia, vascular dementia, etc.)

  • Unable or ineligible to enroll in another clinical trial for their dementia

  • Clear documentation of (1) the patient’s dementia, (2) treatments attempted so far, (3) response to those treatments

  • The investigator and the parent/caregiver must be informed of the potential risks and obligations of the program and decide whether the potential benefit outweighs the risk of receiving an investigational drug therapy based on the patient’s medical history and program eligibility criteria

  • Saliva test results with heterozygous or wild type LGALS3 (rs4644 SNP)

    • Test is available from EndoDNA or IntellxxDNA

    • Test to be conducted with the TB006 Provider and/or staff present

Patient Exclusion Criteria

  • Any significant uncontrolled medical condition

  • Active infection and/or immunosuppressive medical condition

  • Available alternative therapy

  • Major surgery or trauma in the last 14 days

  • Participated in a clinical trial with an investigational drug within the past 6 months

  • Enrolled in a previous TB006 clinical trial and either did not complete the clinical trial or had a significant treatment-related adverse event that could cause an undue risk

  • On non-FDA approved treatments

  • On treatments that may impact TB006 (e.g. Humira and other antibody treatments)

Who Sponsors This Study?

Lead: TrueBinding, Inc.
Source: ClinicalTrials.gov ID: NCT05959239

Related products