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

NCT05476783 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: TB006AD2104
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 13

Brief 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). 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Open-label Extension; TB006; TB006AD2102; De Novo

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events and Serious Adverse Events

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

  Up to 61 weeks

• Number of Participants With Clinically Significant Clinical Laboratory Parameter Values

  Summary of participants with Clinically Significant Clinical Laboratory Parameter Values

  Up to 61 weeks

• Number of Participants With Clinically Significant Vital Sign Values

  Summary of Participants with Clinically Significant Vital Sign Values

  Up to 61 weeks

• Number of Participants With Clinically Significant 12-Lead Electrocardiogram Findings

  Summary of Participants with Clinically Significant 12-Lead electrocardiogram Findings

  Up to 61 weeks

• 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.

  Baseline and up to 61 weeks

• Plasma Concentration of TB006

  Summary of plasma concentration of TB006

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

• Number of Participants With Anti-TB006 Antibodies

  Summary of Participants with Anti-TB006 Antibodies

  Up to 61 weeks

Secondary Outcomes (4)

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

  Baseline and up to Week 101

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

  Baseline and up to Week 101

• Change From Baseline in Neuropsychiatry Inventory (NPI) Score

  Baseline and up to Week 101

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

  Baseline and up to Week 101

Study Arms (1)

TB006 4000 mg

EXPERIMENTAL

TB006 4000 milligram (mg) via a 1-hour continuous intravenous (IV) infusion will be administered once every 28 day

Drug: TB006

Interventions

TB006 DRUG

Clear to slightly opalescent, sterile solution for injection

Also known as: oloctinebart

TB006 4000 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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 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).
• 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.

Sponsors & Collaborators

• TrueBinding, Inc.: lead

Study Sites (13)

Clinical Trial Site

San Diego, California, 92103, United States

Location

Clinical Trial Site

Delray Beach, Florida, 33445, United States

Location

Clinical Trial Site

Lady Lake, Florida, 32159, United States

Location

Clinical Trial Site

Maitland, Florida, 32751, United States

Location

Clinical Trial Site

Miami, Florida, 33135, United States

Location

Clinical Trial Site

Miami, Florida, 33137, United States

Location

Clinical Trial Site

Miami, Florida, 33165, United States

Location

Clinical Trial Site

West Palm Beach, Florida, 33407, United States

Location

Clinical Trial Site

Winter Park, Florida, 32789, United States

Location

Clinical Trial Site

Winter Park, Florida, 32792, United States

Location

Clinical Trial Site

Decatur, Georgia, 30030, United States

Location

Clinical Trial Site

Matthews, North Carolina, 28105, United States

Location

Clinical Trial Site

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

TB006

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: TrueBinding Inc.

info@truebinding.com

650-847-1117

Study Officials

• Alan K Jacobs, MD

  TrueBinding, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: September 15, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)