TB006 is an experimental agent for Alzheimer’s disease. Because of the efficacy and relative safety of this agent it has been approved for compassionate use after Phase II-a trials.
We at Universal Neurological Care have the capability of administering this agent for appropriate candidates that meet eligibility criteria.
Please review the information in this website and consider doing your own research. If interested in moving forward, please try to connect with Dr.Asad for further details.
Expanded Access with TB006 Treatment in Adults with Alzheimer’s Disease and Related Dementias
TB006 Expanded Access Compassionate Use Indication: Alzheimer’s disease (clinical diagnosis) Rationale: Administer TB006 to a patient with Alzheimer's disease (AD) or related dementias who has no other disease-modifying treatment options and are not able to participate in any ongoing clinical trials.
The aim of this protocol is to provide TB006 to patients with AD and related dementias, who have no treatment options and are unable or ineligible to participate in a clinical trial. Other than adverse events (AEs) and serious adverse events (SAEs), no data are collected.
Patients will receive TB006 at a dose of 4,000 mg intravenously over 1 hour every 28 days (± 5 days). The treatment may continue as long as the investigator and patient believe the benefit outweighs the risk, until the Sponsor terminates the protocol or the development of TB006, or TB006 has been approved and marketed in the patient’s respective country.
Safety assessments recommended to be performed in this program include clinical chemistry, hematology and urinalysis analyses, vital signs, electrocardiograms (ECGs), brain magnetic resonance imaging (MRIs) without gadolinium for amyloid-related imaging abnormalities (ARIA) monitoring, Mini-Mental State Examination (MMSE) scores, physical examinations and assessments of AEs, and SAEs. These are to ensure patient safety. All assessments are recorded in the patient’s chart. The Sponsor will only collect AE and SAE data.
This is an open access program, thus there is no limit on the number of patients that can participate.
The following patients may qualify for participation: patients diagnosed with symptomatic AD who have cognitive disability, and whose other medical conditions are stable and well managed. Patients who are not able to receive alternative AD medications, either due to intolerance or contraindication(s), or have taken alternative medications and have not responded. Patients who are unable or ineligible to participate in an AD clinical trial.
Compound: TB006 TrueBinding, Inc. Protocol TB006 Expanded Access Compassionate Use
Protocol Date and Version: 30 May 2023; v 1
Summary of Statistical Considerations: Safety analyses will be performed on all patients who receive any dose of TB006.
AEs will be coded using the most recent version of Medical Dictionary for Regulatory Activities (MedDRA). The incidence of AEs will be summarized by system organ class (SOC) and preferred term (PT). Similarly, summaries will be produced for AEs by severity, SAEs, treatment related AEs, and AEs leading to discontinuation. AEs are collected from the first dose of TB006; thus, all AEs are considered treatment-emergent AEs.
No statistical analyses are planned.
Data Monitoring/Other Committee: No
