Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
NCT ID: NCT05074498
Last Updated: 2023-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
154 participants
INTERVENTIONAL
2021-10-08
2022-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part 1: TB006
Participants will be randomized to 1 of 3 ascending dose groups to receive a total of 5 once-weekly doses of TB006, infused over 1 hour.
TB006
intravenous infusion
Part 1: Placebo
Participants will be randomized to receive 5 once-weekly doses of matching placebo.
Placebo
intravenous infusion
Part 2: TB006
Participants will receive the highest safe and well-tolerated dose identified in Part 1, infused over 1 hour. Randomization will be stratified according to severity at Baseline (mild versus moderate Alzheimer's Disease).
TB006
intravenous infusion
Part 2: Placebo
Participants will be randomized to receive matching placebo. Randomization will be stratified according to severity at Baseline (mild versus moderate Alzheimer's Disease).
Placebo
intravenous infusion
Interventions
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TB006
intravenous infusion
Placebo
intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) score of 24 or less
* Must be ambulatory
* Clinical diagnosis of Alzheimer's Disease (AD) consistent with the following:
1. Probable AD, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Criteria for Major Neurocognitive Disorder (previously dementia)
* Participants or caregiver has the ability to understand the purpose and risks of the study and provide signed and dated informed consent which includes compliance with the requirements and restrictions listed in the inform consent form (ICF) and in this protocol. Participants whose caregiver signs the informed consent must provide their assent.
Exclusion Criteria
* History within the past 6 months or evidence of clinically significant psychiatric illness (e.g., major depression, schizophrenia, or bipolar affective disorder)
* Diagnosis of a dementia-related central nervous system (CNS) disease other than AD (e.g., 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 magnetic resonance imaging (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
50 Years
ALL
No
Sponsors
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TrueBinding, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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TrueBinding, Inc.
Role: STUDY_DIRECTOR
TrueBinding, Inc.
Locations
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Clinical Trial Site
Garden Grove, California, United States
Clinical Trial Site
San Diego, California, United States
Clinical Trial Site
Delray Beach, Florida, United States
Clinical Trial Site
Lady Lake, Florida, United States
Clinical Trial Site #1
Maitland, Florida, United States
Clinical Trial Site
Maitland, Florida, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Stuart, Florida, United States
Clinical Trial Site
West Palm Beach, Florida, United States
Clinical Trial Site
Winter Park, Florida, United States
Clinical Trial Site
Winter Park, Florida, United States
Clinical Trial Site
Decatur, Georgia, United States
Clinical Trial Site
Matthews, North Carolina, United States
Clinical Trial Site
DeSoto, Texas, United States
Clinical Trial Site
Fairfax, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TB006AD2102
Identifier Type: -
Identifier Source: org_study_id
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