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Monoclonal Antibodies

Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With 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

Summary

This trial tests a new drug called TB006 on people with mild to severe Alzheimer's Disease. It aims to find out if the drug is safe, how the body processes it, and if it helps improve their condition. TB006 is a new type of treatment being studied for its potential benefits in Alzheimer's disease.

Eligible Conditions

Alzheimer's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (predose), day 8 (predose), day 36 and day 104

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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%

Blood urea increased

14%

Thyroid function test abnormal

14%

Pyrexia

14%

Gastroenteritis

14%

Sinus tachycardia

14%

Nausea

14%

Asthenia

14%

Fatigue

14%

COVID-19

14%

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Part 2: Placebo

Part 1: TB006 140 Milligrams (mg) Weekly (qw)

Part 1: Placebo

Part 1: TB006 420 mg qw

Part 2: TB006 1000 mg qw

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

Do I qualify?Apply below to find out