Multiple Ascending Dose AL001 for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
iResearch Atlanta & iResearch Savannah, Decatur, GA
Alzheimer Disease+1 More
AL 001 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 2a, single-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Approximately 40 participants will be randomly assigned to receive study drug (active AL001) or placebo. The study consists of a 4-week screening period, a 14-day treatment period, and a 42-day follow-up period.

Eligible Conditions

  • Alzheimer Disease
  • Alzheimer's Disease (AD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: a 42-day follow-up period

a 14-day treatment period
Maximum Tolerated Dose of AL001 in patients with Alzheimers Disease
a 42-day follow-up period
Number of participants with serious AEs, TEAEs that lead to premature discontinuation, abnormal laboratory test results, abnormal ECG readings.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Multiple Ascending Dose AL001
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Multiple Ascending Dose AL001 · Has Placebo Group · Phase 1 & 2

Multiple Ascending Dose AL001
Drug
Experimental Group · 1 Intervention: AL 001 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: a 42-day follow-up period
Closest Location: iResearch Atlanta & iResearch Savannah · Decatur, GA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Alzheimer Disease
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a stage 2, 3, or 4 Alzheimer's disease.
Availability of medical history to provide information about the cognitive and functional level of the participant and of a qualified source such as the caregiver willing and able to provide information about the cognitive and functional level of the participant.
You have a mini-mental state examination score between 16 and 26, inclusive, at Screening.

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.