Status:
UNKNOWN
Study of APH-1105 in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Aphios
Conditions:
Dementia
Alzheimer Disease 1
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 study assessing the safety, tolerability and efficacy of intranasal delivery of APH-1105 for the treatment of mild to moderate Alzheimer's in adult.
Detailed Description
This study is a multi-center, randomized, triple blind placebo-control with parallel groups. Patients diagnosed with mild to moderate AD will be enrolled and randomly assigned in a blinded fashion to ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and Females ages \> 50 years of age at screening visit
- Probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) and Diagnostic Statistical Manual (DSM) IV-V criteria
- Clinical Dementia Rating Scale (CDR) global score \> 1.0 at the time of screening
- Mini-Mental Status Examination score of 22-30 at screening visit CT or MRI of brain, within 12 months prior to randomization, compatible with a diagnosis of Probable Alzheimer's Disease
- Physical examination, laboratory data and electrocardiogram results from screening visit must be normal or abnormal findings must be judged not to be clinically significant
- Ability to walk, at least with an assistive device
- Vision and hearing sufficient to comply with testing
- Informed consent from patient, or legal guardian (if applicable) and a caregiver
- Living outside an institutional facility
- Must have at least 1 informant/study partner
- Exclusion Criteria
- Clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system diseases
- Other neurological disorders, including but not limited to stroke, Parkinson's Disease, seizure disorder, or head injury with loss of consciousness within the past 5 years
- DSM-IV Axis I disorder other than Alzheimer's Disease, including amnesic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder
- CT scan or MRI evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any other clinically significant central nervous system disease
- Dementia complicated by another organic disease
- Dementia complicated by the presence of predominant delusions
- Patients with a hematological malignancy or solid tumor who are undergoing treatment, who have completed treatment within the past 6 months, or who still have evidence of active disease
- Current drug or alcohol dependency including nicotine addiction (smokers)
- Subjects receiving immune-suppressants tricyclic antidepressants anticoagulants or chemotherapeutic agents
- Hypertension that is poorly controlled or managed
- Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
- Clinically significant, unstable psychiatric illness
- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1
- Indication of impaired renal or liver function
- Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
- Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1
- Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.
- Contraindications to study procedures
Exclusion
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03806478
Start Date
June 1 2023
End Date
December 1 2024
Last Update
July 27 2021
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