Alzheimer DiseaseNCT05959239
TB006 Expanded Access (EA) Compassionate Use
A study testing TB006 in people with Alzheimer Disease, run by TrueBinding, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- TB006
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access With TB006 Treatment in Adults With Alzheimer's Disease and Related Dementias
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- TB006
- Keywords
- Alzheimer's Disease, Related Dementias, Expanded Access, TB006
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB006Drug
TB006 will be provided as single-use injectable glass vials.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- TrueBinding, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Truebinding, Inc., Study director, TrueBinding, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959239
- Sponsor's protocol ID
- TB006 EA Compassionate Use
- Status last verified
- Dec 2024
- First submitted
- 14 Jul 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access With TB006 Treatment in Adults With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT05959239
- Acronym / sponsor ID
- TB006 EA Compassionate Use
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Related Dementias, Expanded Access, TB006
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- TrueBinding, Inc.Industry (pharma, biotech, devices)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB006TB006 will be provided as single-use injectable glass vials. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Truebinding, Inc. study director
TrueBinding, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing TB006 in people with Alzheimer Disease, run by TrueBinding, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Truebinding, Inc. (650-847-1117, info@truebinding.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.