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A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Multi-center Open-label Long Term Extension Study to Assess the Safety of TB006 in Patients Who Have Completed Protocol TB006AD2102 and in De Novo Patients With Alzheimer's Disease

NCT05476783•TrueBinding, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

The total study duration for each participant will be up to 113 weeks \[This includes 101 weeks (2 years) of dosing and a 12-week safety follow-up period\]. The number of participants enrolled from the lead-in study will be 100 to 120 and additionally, up to 50 de novo participants, identified by the sponsor, may be included. A total of approximately 150 to 180 participants will be enrolled.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+10 more criteria

Exclusion Criteria

•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
•1. 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
•2. History within the past 6 months or evidence of clinically significant psychiatric illness like major depression, schizophrenia, or bipolar affective disorder
•3. 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).
•4. Identification of other known cause of dementia or any other clinically significant contributing co-morbid pathologies at screening MRI
•5. Any contraindications to having a brain MRI eg, pacemaker; non-MRI compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia)
•6. Any untreated or unstable clinically significant medical condition like hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, or depression
•7. Any clinically significant findings in medical examination, including physical examination, 12-lead electrocardiogram (ECG), clinical laboratory tests.
•8. Undergone major surgery \<= 2 months before study drug administration.
+23 more criteria

Locations (13)

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

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

West Palm Beach, Florida, United States

Clinical Trial Site

Winter Park, Florida, United States

Clinical Trial Site

Winter Park, Florida, United States

Key Dates

Start Date

September 14, 2022

Primary Completion Date

November 17, 2023

Completion Date

November 17, 2023

Last Updated

December 10, 2024

Enrollment

180

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

TB006

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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