UnknownPhase 2

Study of APH-1105 in Patients With Mild to Moderate Alzheimer's Disease

Safety, Tolerability and Efficacy Assessment of Intranasal Nanoparticles of APH-1105, A Novel Alpha Secretase Modulator For Mild to Moderate Cognitive Impairment Due to Alzheimer's Disease(AD)

Lead sponsor

Aphios

Asset

APH-1105

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoints

•Safety•ADAS-Cog•Efficacy

Identifiers

Registered as

Org study IDAPH-1105

NCT IDNCT03806478

Timeline

Milestones

Study first posted2019-01-16actual

Last update posted2021-07-27actual

Study start2023-06estimated (month precision)

Primary completion2024-09estimated (month precision)

Study completion2024-12estimated (month precision)

Assets

Drug assets

APH-1105

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Behavior / neuropsychiatric

Memory

Caregiver / quality of life

Other (unclassified)

Global cognition

2 endpoints

Primary/protocol endpoint

Efficacy: Cognition Change

Time frame:Baseline - day 60

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Dementia Symptom Severity

Time frame:Baseline, week 4, 8 12 and week 16 post final dose.

change from baseline, improvement

Memory

1 endpoint

Primary/protocol endpoint

Efficacy: Change in Cognitive Functioning

Time frame:Baseline - day 60

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change in Behavioral Disturbance

Time frame:Baseline, week 4, 8 12 and week 16 post final dose.

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Risk of Suicide

Time frame:Baseline, week 4, 8, 12 and week 16 post final dose

categorical status, descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Evaluate the Quality of Life Status

Time frame:Baseline, week 4, 8, 12 and week 16 post final dose

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Safety: Incidence of Treatment-emergent Adverse Events

Time frame:Baseline through 30 days post final treatment dose up to day 60

event count, event

Secondary/protocol endpoint

Tolerability: [Pharmacokinetics] Cmax

Time frame:Blood draws at baseline and 15 minutes, 30minutes, 60minutes, 2 hours, 6hours, 12hours, 24hours, 48hours and 72hours post first administered dose

concentration, descriptive

Secondary/protocol endpoint

Tolerability: [Pharmacokinetics] Tmax

Time frame:Blood draws at baseline and 15 minutes, 30minutes, 60minutes, 2 hours, 6hours, 12hours, 24hours, 48hours and 72hours post first administered dose

concentration, descriptive

Secondary/protocol endpoint

Tolerability: [Pharmacokinetics] serum elimination half life

Time frame:Blood draws at baseline and 15 minutes, 30minutes, 60minutes, 2 hours, 6hours, 12hours, 24hours, 48hours and 72hours post first administered dose

concentration, descriptive

Secondary/protocol endpoint

Tolerability: [Pharmacodynamics] protein kinase C activity

Time frame:Blood draws at baseline, 15 minutes, 30minutes, 60minutes, 2hours, 6hours, 12hours, 24hours, 48hours, and 72hours post first administered dose.

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Behavioral Functioning

Time frame:Baseline, week 4, 8 12 and week 16 post final dose.

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.