A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease (NCT05476783) | Clinical Trial Compass
TerminatedPhase 2
A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease
Stopped: Resource Constraints
United States119 participantsStarted 2022-09-15
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
ā. Probable AD, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
ā. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Criteria for Major Neurocognitive Disorder (previously dementia).
Exclusion criteria
ā. 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
ā. History within the past 6 months or evidence of clinically significant psychiatric illness like major depression, schizophrenia, or bipolar affective disorder
ā. 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).
ā. Identification of other known cause of dementia or any other clinically significant contributing co-morbid pathologies at screening MRI
ā. Any contraindications to having a brain MRI eg, pacemaker; non-MRI compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia)
What they're measuring
1
Number of Participants With Adverse Events and Serious Adverse Events
Timeframe: Up to 61 weeks
2
Number of Participants With Clinically Significant Clinical Laboratory Parameter Values
Timeframe: Up to 61 weeks
3
Number of Participants With Clinically Significant Vital Sign Values
Timeframe: Up to 61 weeks
4
Number of Participants With Clinically Significant 12-Lead Electrocardiogram Findings
Timeframe: Up to 61 weeks
5
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
Timeframe: Baseline and up to 61 weeks
6
Plasma Concentration of TB006
Timeframe: Pre-dose, and Weeks 1, 5, 9, 13, 17, 21, 25, 45, 73, 101, 113 and ED/EOS up to Week 61
ā. Any untreated or unstable clinically significant medical condition like hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, or depression
ā. Any clinically significant findings in medical examination, including physical examination, 12-lead electrocardiogram (ECG), clinical laboratory tests.
ā. Undergone major surgery \<= 2 months before study drug administration.