An Open-label Long-term Safety Study of Buntanetap in Participants With AD
ConditionAlzheimer's Dementia (AD)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age55+
SponsorAnnovis Bio Inc.
About this trial
This study will examine the long-term safety of buntanetap in participants with AD who have participated in a prior study of buntanetap in AD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has participated in a prior Alzheimer's clinical trial with buntanetap.
Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (minimum 10 hours per week), and will accompany the participant on study visits at designated times.
Female participants of childbearing potential must have a negative urine pregnancy test at screening, be non-lactating, and must agree to use a highly effective method of contraception.
Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male participants must adopt a highly effective method of contraception.
Disqualifiers
Has history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the DSM, unless they are stable on treatment. Mild depression or history of depression that is stable on treatment with SSRI or SNRI at a stable dose is permitted.
Has non-AD dementia, such as vascular dementia, Lewy Body dementia, frontotemporal dementia, Parkinson's disease dementia, B12 and thyroid deficiency cause dementia.
History of seizure disorder, but if stable on medication is acceptable.
ANVS-25001 legacy participants: screening MRI of brain indicative of significant abnormality, including but not limited to, prior hemorrhage (>5 microhemorrhages) or infarct >1cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abcess or brain tumor such as meningioma, unless they are documented and stable).
Trial design
Design model
Single group
Treatments tested in this trial
buntanetap/posiphen
Drugbuntanetap 30 mg daily
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of buntanetap
Safety assessments of participants with AD receiving treatment with buntanetap
Time frame
24 months of treatment2
Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
Time frame
24 months of study3
Treatment Emergent Adverse Events (TEAE)
TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
Time frame
24 months of study4
Serious Adverse Events (SAE)
SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly
Time frame
24 months of studyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: