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TB006 Expanded Access (EA) Compassionate Use

Primary Purpose

Alzheimer Disease

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
TB006
Sponsored by
TrueBinding, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Related Dementias, Expanded Access, TB006

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All Sexes

Inclusion criteria: Male and/or female participants > 55 years of age at the time of signing the informed consent. The participant is diagnosed with symptomatic AD or related dementia, meeting the clinical criteria for AD with an estimated or actual Mini-Mental State Examination (MMSE) score or 24 or less. All other medical conditions are stable and well managed. Clinical diagnosis of AD is consistent with the following: Probable AD, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA). Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) - Criteria for Major Neurocognitive Disorder (previously dementia). There must be clear documentation of the participant's declining cognitive and functional status, any and all treatments attempted, and response (or lack of) to treatments. The participant is not able to receive any of the current anti-AD medicines either due to intolerance or contraindication(s); or the participant's dementia has persistently declined despite receiving maximum allowable or tolerated doses of current anti-AD medicines, including aducanumab and lecanemab. The participant is unable or ineligible to enroll in another clinical trial for their condition. This is defined as: No ongoing trial for which the participant may qualify. An ongoing trial, but the participant does not qualify. No ongoing trial site within 50 miles of the participant's home. The investigator as well as the participant/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 therapy based on the participant's medical history and program eligibility criteria. The participant, and/or, in the case of reduced decision-making capacity, the legally acceptable representative(s) consistent with national law and ethics approval is/are able to read, understand, and provide written informed consent. Has one (or more) identified adult program partner who either lives with the participant or has sufficient contact to provide assessment of changes in participant behavior and function over time and information on safety and tolerability; is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the clinic; agrees to accompany the participant to each program visit. Able to comply with the program procedures, including the ability to travel to the named clinic for monthly visits. Exclusion criteria: Any clinically significant or uncontrolled medical condition, including but not limited to cardiovascular disease, respiratory disorder, malignancy, and hematology or clinical chemistry abnormality. Has undergone major surgery or experienced trauma in the last 14 days. Any condition or emergent intercurrent illness that, in the judgment of the investigator, could result in the risk of participation outweighing the potential benefit. Unable to comply with this program protocol or has health concerns that may increase risk, in the opinion of the investigator. Participated in a clinical trial with an investigation 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 (AE) that could cause an undue risk.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    July 14, 2023
    Sponsor
    TrueBinding, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05959239
    Brief Title
    TB006 Expanded Access (EA) Compassionate Use
    Official Title
    Expanded Access With TB006 Treatment in Adults With Alzheimer's Disease and Related Dementias
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TrueBinding, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label, expanded access, compassionate use treatment protocol of TB006 treatment in participants who meet clinical diagnostic criteria for Alzheimer's disease (AD). Participants will receive TB006 at a dose of 4,000 milligrams (mg) intravenous (IV) over 1 hour every 28 days ± 5 days.
    Detailed Description
    A participant's physician who is interested in participating in this program will need to go to the company's website for further information and application forms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease
    Keywords
    Alzheimer's Disease, Related Dementias, Expanded Access, TB006

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    TB006
    Intervention Description
    TB006 will be provided as single-use injectable glass vials.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Eligibility Criteria
    Inclusion criteria: Male and/or female participants > 55 years of age at the time of signing the informed consent. The participant is diagnosed with symptomatic AD or related dementia, meeting the clinical criteria for AD with an estimated or actual Mini-Mental State Examination (MMSE) score or 24 or less. All other medical conditions are stable and well managed. Clinical diagnosis of AD is consistent with the following: Probable AD, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA). Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) - Criteria for Major Neurocognitive Disorder (previously dementia). There must be clear documentation of the participant's declining cognitive and functional status, any and all treatments attempted, and response (or lack of) to treatments. The participant is not able to receive any of the current anti-AD medicines either due to intolerance or contraindication(s); or the participant's dementia has persistently declined despite receiving maximum allowable or tolerated doses of current anti-AD medicines, including aducanumab and lecanemab. The participant is unable or ineligible to enroll in another clinical trial for their condition. This is defined as: No ongoing trial for which the participant may qualify. An ongoing trial, but the participant does not qualify. No ongoing trial site within 50 miles of the participant's home. The investigator as well as the participant/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 therapy based on the participant's medical history and program eligibility criteria. The participant, and/or, in the case of reduced decision-making capacity, the legally acceptable representative(s) consistent with national law and ethics approval is/are able to read, understand, and provide written informed consent. Has one (or more) identified adult program partner who either lives with the participant or has sufficient contact to provide assessment of changes in participant behavior and function over time and information on safety and tolerability; is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the clinic; agrees to accompany the participant to each program visit. Able to comply with the program procedures, including the ability to travel to the named clinic for monthly visits. Exclusion criteria: Any clinically significant or uncontrolled medical condition, including but not limited to cardiovascular disease, respiratory disorder, malignancy, and hematology or clinical chemistry abnormality. Has undergone major surgery or experienced trauma in the last 14 days. Any condition or emergent intercurrent illness that, in the judgment of the investigator, could result in the risk of participation outweighing the potential benefit. Unable to comply with this program protocol or has health concerns that may increase risk, in the opinion of the investigator. Participated in a clinical trial with an investigation 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 (AE) that could cause an undue risk.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Truebinding, Inc.
    Phone
    650-847-1117
    Email
    info@truebinding.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Truebinding, Inc.
    Organizational Affiliation
    TrueBinding, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://truebinding.com/expanded-access
    Description
    Related Info

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    TB006 Expanded Access (EA) Compassionate Use

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