Treatment for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Collaborative Neuroscience Research, LLC., 2600 Redondo Ave., Long Beach, CA
Alzheimer Disease+2 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. the starting dose of APNmAb005 is 5 mg/kg and the anticipated doses for subsequent cohorts are 10, 25, 50 and 70 mg/kg. A Safety Review Team (SRT) will review data on an ongoing basis throughout the study and before progression to the next dose level cohort. Subjects will receive a single dose of either APNmAb005 or placebo administered as a single IV infusion on Day 1 of the study and will remain in the study center until Day 3 (48 hours after dosing). They will return to the study center for 7 outpatient visits. The duration of the study, excluding screening, is approximately 71 days.

Eligible Conditions

  • Alzheimer Disease
  • Healthy Subjects (HS)
  • Tauopathies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alzheimer Disease

Study Objectives

7 Primary · 30 Secondary · Reporting Duration: Day 70

Baseline and Day 14
Mean change in Total tau concentration in CSF
Mean change in p-tau 181 concentration in CSF
Mean change in p-tau 217 concentration in CSF
Mean change in p-tau 231 concentration in CSF
Baseline and Day 70
Mean change in Total tau concentration in plasma
Mean change in p-tau 181 concentration in plasma
Mean change in p-tau 217 concentration in plasma
Mean change in p-tau 231 concentration in plasma
Day 70
Number of participants with Clinical Laboratory Abnormalities
Number of participants with Electrocardiogram (ECG) Abnormalities
Number of participants with Vital Sign Abnormalities
Number of subjects with AEs resulting in Study Discontinuation
Number of subjects with Adverse Events (AEs)
Number of subjects with Serious Adverse Events (SAEs)
Number of subjects with Treatment-emergent AEs (TEAEs)
Thru Day 14
AUC0-t of APNmAb005 in CSF
CL of APNmAb005 in CSF
Cmax of APNmAb005 in CSF
Mean Total tau concentration in CSF
Mean p-tau 181 concentration in CSF
Mean p-tau 217 concentration in CSF
Mean p-tau 231 concentration in CSF
Tmax of APNmAb005 in CSF
Vd of APNmAb005 in CSF
t1/2 of APNmAb005 in CSF
Thru Day 70
AUC0-t of APNmAb005 in plasma
CL of APNmAb005 in blood.
Cmax of APNmAb005 in blood
Mean Total tau concentration in plasma
Mean p-tau 181 concentration in plasma
Mean p-tau 217 concentration in plasma
Mean p-tau 231 concentration in plasma
Number of participants with ADA formation against APNmAb005
Number of participants with no ADA formation against APNmAb005
Tmax of APNmAb005 in blood
Vd of APNmAb005 in plasma
t1/2 of APNmAb005 in plasma

Trial Safety

Safety Progress

1 of 3

Other trials for Alzheimer Disease

Trial Design

5 Treatment Groups

APNmAb005 (5mg/kg) vs Placebo
1 of 5
APNmAb005 (10 mg/kg) vs Placebo
1 of 5
APNmAb005 (25 mg/kg) vs Placebo
1 of 5
APNmAb005 (50 mg/kg) vs Placebo
1 of 5
APNmAb005 (70 mg/kg) vs Placebo
1 of 5
Active Control

40 Total Participants · 5 Treatment Groups

Primary Treatment: Treatment · Has Placebo Group · Phase 1

APNmAb005 (5mg/kg) vs PlaceboActiveComparator Group · 2 Interventions: APNmAb005, Placebo · Intervention Types: Drug, Drug
APNmAb005 (10 mg/kg) vs PlaceboActiveComparator Group · 2 Interventions: APNmAb005, Placebo · Intervention Types: Drug, Drug
APNmAb005 (25 mg/kg) vs PlaceboActiveComparator Group · 2 Interventions: APNmAb005, Placebo · Intervention Types: Drug, Drug
APNmAb005 (50 mg/kg) vs PlaceboActiveComparator Group · 2 Interventions: APNmAb005, Placebo · Intervention Types: Drug, Drug
APNmAb005 (70 mg/kg) vs PlaceboActiveComparator Group · 2 Interventions: APNmAb005, Placebo · Intervention Types: Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 70
Closest Location: Collaborative Neuroscience Research, LLC., 2600 Redondo Ave. · Long Beach, CA
Photo of california 1Photo of california 2Photo of california 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Alzheimer Disease
0 CompletedClinical Trials

Who is running the clinical trial?

APRINOIA Therapeutics, LLCLead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Alzheimer Disease
130 Patients Enrolled for Alzheimer Disease
Steven Reynolds, DOPrincipal InvestigatorCollaborative Neuroscience Research, LLC.

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must be female, aged 18 years or older, and not pregnant, surgically sterile, postmenopausal, or using an acceptable method of birth control.
You have given informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.