An Open-label Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease.

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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) and 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 approximately 113 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TrueBinding, Inc.

Criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if they meet the following criteria:

• Completed Protocol TB006AD2102 (Participants from both study drug and placebo groups).

• Participants who have a gap of more than 28 days between Study TB006AD2102 completion and enrolment in current study, their eligibility must be reconfirmed by the investigator, and such participants will undergo screening procedures in the current OLE protocol.

• 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 should 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.

Exclusion Criteria:

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

• Any of the following emerging medical or psychiatric exclusion criteria as defined in the lead-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 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 ECG, clinical laboratory tests

8. Undergone major surgery <= 2 months before study drug administration

9. 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.

10. 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. One unit is equivalent to 8 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 Covid-19-positive at Screening (or 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.