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Alzheimer's DiseasePhase 2NCT05476783

A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease

A Phase 2 study testing TB006 in people with Alzheimer's Disease, run by TrueBinding, Inc. at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label long term extension study for participants with Alzheimer's disease (AD) who have completed Protocol TB006AD2102 (lead-in study) or participants who would have been eligible for the lead-in study but were not enrolled (de novo). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
TB006
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
13 sitesUnited States
Study dates
15 Sep 2022to 17 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Lead-in study participants are eligible to be included in the study only if they meet the following criteria:
  • Completed lead-in Protocol TB006AD2102 (Participants from both study drug and placebo groups) or are eligible for the lead-in study but were not enrolled (de novo).
  • Eligibility must be reconfirmed by the investigator for participants who have a gap of more than 28 days between lead-in Protocol TB006AD2102 completion and enrolment in the current study. These participants will undergo the screening procedures in the current Open-label extension (OLE) protocol, with the exception of imaging.
  • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Females must be of non-childbearing potential.
  • Participants or caregiver has the ability to understand the purpose and risks of the study and provide signed and dated informed consent. Participants whose caregiver signs the informed consent must provide their assent.
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  • Either currently or previously (in pre-AD condition) literate and capable of reading, writing, and communicating effectively with others.
  • Participants, along with the caregiver, will be compliant with study visits, procedure.
  • De novo participants, identified by the sponsor and referred to a participating site, are eligible to be included in the study only if all of the following criteria apply:
  • Male and/or female > 50 years of age at the time of signing the informed consent.
  • Body weight of ≥ 50 kilograms (kg) and body mass index (BMI) between 18 and 35 kilograms per square meter (kg/m^2), inclusive.
  • MMSE score of 24 or less.
  • Must be ambulatory.
  • Clinical diagnosis of AD consistent with the following:
  • Probable AD, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Criteria for Major Neurocognitive Disorder (previously dementia).
  • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Females must be of non-childbearing potential.
  • Participants or caregiver has the ability to understand the purpose and risks of the study and provide signed and dated informed consent. Participants whose caregiver signs the informed consent must provide their assent.
  • Either currently or previously (in pre-AD condition) literate and capable of reading, writing, and communicating effectively with others.

Who cannot join

  • Lead-in study participants are excluded from the study if any of the following criteria apply:
  • Development of an intolerable adverse event or an adverse event that was considered an important safety risk in Protocol TB006AD2102
  • Any of the following emerging medical or psychiatric exclusion criteria as defined in the lead-in Protocol TB006AD2102:
  • Any medical or neurological condition other than AD that in the opinion of the investigator could be a contributing cause of the Participant's dementia
  • History within the past 6 months or evidence of clinically significant psychiatric illness like major depression, schizophrenia, or bipolar affective disorder
  • Diagnosis of a dementia-related central nervous system (CNS) disease other than AD (eg, Parkinson's Disease, Huntington's Disease, frontotemporal dementia, multi-infarct dementia, dementia with Lewy bodies, or normal pressure hydrocephalus).
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  • Identification of other known cause of dementia or any other clinically significant contributing co-morbid pathologies at screening MRI
  • Any contraindications to having a brain MRI eg, pacemaker; non-MRI compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia)
  • Any untreated or unstable clinically significant medical condition like hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, or depression
  • Any clinically significant findings in medical examination, including physical examination, 12-lead electrocardiogram (ECG), clinical laboratory tests.
  • Undergone major surgery <= 2 months before study drug administration.
  • Loss of more than 100 milliliters (mL) blood (eg, a blood donation) within 2 months before first study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before Day 1, or plans to donate blood during the study or within 3 months after the study.
  • Regular alcohol consumption within 6 months prior to the study defined as: an average weekly (QW) intake of > 20 units for males or > 16 units for females. One unit is equivalent to 8 grams (g) of alcohol.
  • Meets DSM-5 criteria for moderate or severe substance use disorder within the past 12 months, or has a positive test for substances of abuse, or has used substances, including but not limited to opiates, methadone, buprenorphine, methamphetamine, cocaine, amphetamines recreationally within the past 12 months.
  • Unable to complete this study for other reasons or the investigator believes the Participant should be excluded.
  • Since participating in Protocol TB006AD2102, the participant has participated in another drug, biologic, device, or a clinical study or treatment with an investigational drug or approved therapy for investigational use.
  • Any clinically significant findings in medical examination. This includes physical examination, 12-lead ECG, or clinical laboratory tests on the final visit in Protocol TB006AD2102 or on the Baseline visit in this study. Participants who are coronavirus disease of 2019 (COVID-19)-positive at Screening (or end of treatment [EOT] from lead-in study) must delay the start of the study until they are COVID-19-negative. They may be retested at weekly intervals.
  • Participants who have undergone major surgery since enrolment in Protocol TB006AD2102 will be considered on a case-by-basis.
  • De Novo participants are excluded from the study if any of the following criteria apply:
  • Any medical or neurological condition other than AD that in the opinion of the investigator could be a contributing cause of the participant's dementia
  • History within the past 6 months or evidence of clinically significant psychiatric illness (eg, major depression, schizophrenia, or bipolar affective disorder).
  • Diagnosis of a dementia-related CNS disease other than AD (eg, Parkinson's Disease, Huntington's Disease, frontotemporal dementia, multi-infarct dementia, dementia with Lewy bodies, normal pressure hydrocephalus).
  • Identification of other known cause of dementia or any other clinically significant contributing co-morbid pathologies at screening MRI, in the opinion of the investigator.
  • Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to screening, and/or participation in any other clinical study involving experimental medications for AD within the 60 days (or 5 half-lives, whichever is longer) prior to screening.
  • Any contraindications to having a brain MRI eg, pacemaker; non-MRI-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia).
  • Any untreated or unstable clinically significant medical condition (ie, hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression, etc.) as judged by the investigator.
  • Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, clinical laboratory tests.
  • Undergone major surgery <= 2 months before study drug administration.
  • Loss of more than 100 mL blood (eg, a blood donation) within 2 months before first study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before Day 1, or plans to donate blood during the study or within 3 months after the study.
  • Recent (3-month) history of a positive COVID-19 test result or disease symptoms of COVID-19 disease such as shortness of breath, cough, rhinorrhea, and sore throat, etc.
  • Known history of, or a positive test result for Hepatitis B surface antigen (HBsAg), immunoglobulin M antibody to Hepatitis B core antigen (IgM anti HBc), anti-hepatitis C virus antibodies (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening. Participants with a documented history of treatment for Hepatitis C are otherwise eligible to participate.
  • Regular alcohol consumption within 6 months prior to the study defined as: an average QW intake of > 20 units for males or > 16 units for females.
  • Meets DSM-5 criteria for moderate or severe substance use disorder within the past 12 months, or has a positive test for substances of abuse, or has used substances, including but not limited to opiates, methadone, buprenorphine, methamphetamine, cocaine, amphetamines recreationally within the past 12 months.
  • Unable to complete this study for other reasons or the investigator believes that he or she should be excluded.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Clinical Trial Site

    Decatur, Georgia, 30030

  • Clinical Trial Site

    Delray Beach, Florida, 33445

  • Clinical Trial Site

    Fairfax, Virginia, 22031

  • Clinical Trial Site

    Lady Lake, Florida, 32159

  • Clinical Trial Site

    Maitland, Florida, 32751

  • Clinical Trial Site

    Matthews, North Carolina, 28105

  • Clinical Trial Site

    Miami, Florida, 33135

  • Clinical Trial Site

    Miami, Florida, 33137

  • Clinical Trial Site

    Miami, Florida, 33165

  • Clinical Trial Site

    San Diego, California, 92103

  • Clinical Trial Site

    West Palm Beach, Florida, 33407

  • Clinical Trial Site

    Winter Park, Florida, 32789

  • Clinical Trial Site

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: A Multi-center Open-label Long Term Extension Study to Assess the Safety of TB006 in Patients Who Have Completed Protocol TB006AD2102 and in De Novo Patients With Alzheimer's Disease

This is an open-label long term extension study for participants with Alzheimer's disease (AD) who have completed Protocol TB006AD2102 (lead-in study) or participants who would have been eligible for the lead-in study but were not enrolled (de novo). The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TB006. The total study duration for each participant will be up to 113 weeks.

Read the detailed description

The total study duration for each participant will be up to 113 weeks [This includes 101 weeks (2 years) of dosing and a 12-week safety follow-up period]. The number of participants enrolled from the lead-in study will be 100 to 120 and additionally, up to 50 de novo participants, identified by the sponsor, may be included. A total of approximately 150 to 180 participants will be enrolled.

Being tested
TB006
Keywords
Alzheimer's disease, Open-label Extension, TB006, TB006AD2102, De Novo
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

    Also called oloctinebart

    Clear to slightly opalescent, sterile solution for injection

Study groups in NCT05476783
Study groupRoleWhat they receive
TB006 4000 mgExperimentalTB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day
Receives: Drug: TB006

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events and Serious Adverse Events

    Summary for Number of Participants with Adverse Events and Serious Adverse Events

    Measured: Up to 61 weeks

  2. Number of Participants With Clinically Significant Clinical Laboratory Parameter Values

    Summary of participants with Clinically Significant Clinical Laboratory Parameter Values

    Measured: Up to 61 weeks

  3. Number of Participants With Clinically Significant Vital Sign Values

    Summary of Participants with Clinically Significant Vital Sign Values

    Measured: Up to 61 weeks

  4. Number of Participants With Clinically Significant 12-Lead Electrocardiogram Findings

    Summary of Participants with Clinically Significant 12-Lead electrocardiogram Findings

    Measured: Up to 61 weeks

  5. Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale with 0: no suicidal behavior and 5: active suicidal ideation. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25). Higher scores in the scale indicate greater disease severity. An increase from baseline in the total score of C-SSRS >=1 is considered as an adverse change.

    Measured: Baseline and up to 61 weeks

  6. Plasma Concentration of TB006

    Summary of plasma concentration of TB006

    Measured: Pre-dose, and Weeks 1, 5, 9, 13, 17, 21, 25, 45, 73, 101, 113 and ED/EOS up to Week 61

  7. Number of Participants With Anti-TB006 Antibodies

    Summary of Participants with Anti-TB006 Antibodies

    Measured: Up to 61 weeks

Secondary outcomes (4)

  1. Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR SB) Score

    The CDR scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None = 0, Questionable = 0.5, Mild = 1, Moderate = 2, and Severe = 3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.

    Measured: Baseline and up to Week 101

  2. Change From Baseline in Mini Mental State Examination (MMSE) Score

    Global cognitive functioning is measured by MMSE. MMSE is a neuropsychological test for the evaluation of intellectual efficiency disorders and the presence of cognitive impairment. The total score is between a minimum of 0 (worse cognitive function) and a maximum of 30 points (normal cognitive function). A lower score indicates severe impairment of cognitive abilities and a higher score indicates cognitive normality.

    Measured: Baseline and up to Week 101

  3. Change From Baseline in Neuropsychiatry Inventory (NPI) Score

    The NPI is a condition-specific measure designed to assess 12 behavioral disturbances, namely delusions, hallucinations, depression/dysphoria, anxiety, agitation/aggression, elation/euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite/eating abnormalities. The frequency is scored from 0 (never) to 4 (very frequently) and severity ranges between 0 (none) to 3 (marked). The domain score is obtained by multiplying frequency and severity scores. The total NPI score is the sum total of all individual domain scores (0-144). A higher score indicates abnormal behaviour.

    Measured: Baseline and up to Week 101

  4. Change From Baseline in EuroQol 5 Dimension 5-Level Quality of Life (EQ 5D 5L QoL) Total Score

    EuroQol 5 is a self-reported description of participant's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants to grade their own current level of function in each dimension into one of three degrees of disability (severe, moderate or none). Score ranges between 1 (no problem) and 3 (significant problem). higher scores indicating higher health utility. The total score is the sum total of all individual domain scores (5-15). Higher scores indicates poor quality of life.

    Measured: Baseline and up to Week 101

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start15 Sep 2022
  3. Primary completion17 Nov 2023
  4. Study completion17 Nov 2023

Why it stopped: Resource Constraints

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05476783
Sponsor's protocol ID
TB006AD2104
Status last verified
Apr 2026
First submitted
25 Jul 2022
Last updated
6 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TB006 in people with Alzheimer's Disease, run by TrueBinding, Inc. at 13 sites in United States.

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 20 inclusion and 34 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: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events and Serious Adverse Events (time frame: Up to 61 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05476783.

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 6 May 2026.

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