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

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.
• •9. Loss of more than 100 milliliters (mL) blood (eg, a blood donation) within 2 months before first study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before Day 1, or plans to donate blood during the study or within 3 months after the study.
• •10. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly (QW) intake of \> 20 units for males or \> 16 units for females. One unit is equivalent to 8 grams (g) of alcohol.
• •11. Meets DSM-5 criteria for moderate or severe substance use disorder within the past 12 months, or has a positive test for substances of abuse, or has used substances, including but not limited to opiates, methadone, buprenorphine, methamphetamine, cocaine, amphetamines recreationally within the past 12 months.
• •12. Unable to complete this study for other reasons or the investigator believes the Participant should be excluded.
• •Since participating in Protocol TB006AD2102, the participant has participated in another drug, biologic, device, or a clinical study or treatment with an investigational drug or approved therapy for investigational use.
• •Any clinically significant findings in medical examination. This includes physical examination, 12-lead ECG, or clinical laboratory tests on the final visit in Protocol TB006AD2102 or on the Baseline visit in this study. Participants who are coronavirus disease of 2019 (COVID-19)-positive at Screening (or end of treatment \[EOT\] from lead-in study) must delay the start of the study until they are COVID-19-negative. They may be retested at weekly intervals.
• •Participants who have undergone major surgery since enrolment in Protocol TB006AD2102 will be considered on a case-by-basis.
• •De Novo participants are excluded from the study if any of the following criteria apply:
• •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
• •History within the past 6 months or evidence of clinically significant psychiatric illness (eg, major depression, schizophrenia, or bipolar affective disorder).
• •Diagnosis of a dementia-related CNS disease other than AD (eg, 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 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.
• •Any contraindications to having a brain MRI eg, pacemaker; non-MRI-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia).
• •Any untreated or unstable clinically significant medical condition (ie, hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression, etc.) as judged by the investigator.
• •Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, clinical laboratory tests.
• •Undergone major surgery \<= 2 months before study drug administration.
• •Loss of more than 100 mL blood (eg, a blood donation) within 2 months before first study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before Day 1, or plans to donate blood during the study or within 3 months after the study.
• •Recent (3-month) history of a positive COVID-19 test result or disease symptoms of COVID-19 disease such as shortness of breath, cough, rhinorrhea, and sore throat, etc.
• •Known history of, or a positive test result for Hepatitis B surface antigen (HBsAg), immunoglobulin M antibody to Hepatitis B core antigen (IgM anti HBc), anti-hepatitis C virus antibodies (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening. Participants with a documented history of treatment for Hepatitis C are otherwise eligible to participate.
• •Regular alcohol consumption within 6 months prior to the study defined as: an average QW intake of \> 20 units for males or \> 16 units for females.
• •Meets DSM-5 criteria for moderate or severe substance use disorder within the past 12 months, or has a positive test for substances of abuse, or has used substances, including but not limited to opiates, methadone, buprenorphine, methamphetamine, cocaine, amphetamines recreationally within the past 12 months.
• •Unable to complete this study for other reasons or the investigator believes that he or she should be excluded.