NCT03806478

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aphios · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 receive study drug APH-1105. Groups will receive either 0.5 µg (15 active, 5 placebo), 1.0 µg (15 active, 5 placebo), or 2.0 µg (15 active, 5 placebo). A full assessment will be made of all relevant tolerability and safety data. Patients will be administered the study drug outside of the clinic setting by a study partner twice a week. The initial dose of APH-1105 will take place in a clinic setting for the purpose of collecting initial Pharmacokinetic data. The total duration for patient participation will be approximately 18 weeks which includes 1 week for screening, 12 weeks of treatment and followup 4 weeks post final dose. Study visits will occur during screening, baseline, weeks 1, 2, 4, 8, 12 and 16 for a total of 7 visits. Week 16 represents the followup visit after the final dose of study medication. Cognitive assessments will be performed at screening, and will repeat at weeks 4, 12 and 16. Behavioral Functioning and Quality of Life measures will be done at weeks 2,4,8,12 and 16. Blood samples will collected though out the study for Pharmacokinetic analyses.

Conditions

• Dementia
• Alzheimer Disease 1
• Alzheimer Disease 2
• Alzheimer Disease 3

Interventions

Type	Name	Description
DRUG	APH-1105	The investigational drug product, APH-1105 is a sterile, pyrogen-free lyophilized powder intended for intranasal administration.
OTHER	Placebo	The placebo is a sterile, pyrogen free lyophilized powder identical in appearance to the experimental drug

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2019-01-16
• Last updated: 2021-07-27