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Monoclonal Antibodies

TB006 for Alzheimer's Disease

Phase 1 & 2
Waitlist Available
Research Sponsored by TrueBinding, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (predose), day 8 (predose), day 36 and day 104
Awards & highlights

Study Summary

This trial will test the safety and efficacy of a new drug, TB006, on people with Alzheimer's Disease.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (predose), day 8 (predose), day 36 and day 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (predose), day 8 (predose), day 36 and day 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Part 1: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C
Part 1: Change From Baseline in Clinical Chemistry Parameter: Thyrotropin
+31 more
Secondary outcome measures
Part 2: Change From Baseline Through Day 36 on the Clinical Dementia Rating Scale - Sum of Boxes Total Score
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Part 2: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C
+29 more

Side effects data

From 2022 Phase 1 & 2 trial • 154 Patients • NCT05074498
14%
Fatigue
14%
COVID-19
14%
Thyroid function test abnormal
14%
Sinus tachycardia
14%
Asthenia
14%
Pyrexia
14%
Nausea
14%
Blood urea increased
14%
Gastroenteritis
14%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Placebo
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
Part 1: TB006 420 mg qw
Part 2: TB006 1000 mg qw
Part 2: Placebo
Part 1: TB006 1000 mg qw

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: TB006Experimental Treatment1 Intervention
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).
Group II: Part 1: TB006Experimental Treatment1 Intervention
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.
Group III: Part 2: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive matching placebo. Randomization will be stratified according to severity at Baseline (mild versus moderate Alzheimer's Disease).
Group IV: Part 1: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive 5 once-weekly doses of matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TB006
2021
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

TrueBinding, Inc.Lead Sponsor
5 Previous Clinical Trials
228 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am not qualified for other clinical trials due to my MMSE scores being too low or needing a translator as my English is second language.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Clinical Trial Site: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
2021. "Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05074498.
~44 spots leftby Apr 2025
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