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Monoclonal Antibodies

AL 001 for Alzheimer's Disease ("MAD" Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Alzamend Neuro, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up a 42-day follow-up period

Awards & highlights

"MAD" Trial Summary

This trial is testing a new drug, AL001, to see if it is safe and what the maximum tolerated dose is. 40 people will be given the drug or a placebo, and the study will last for 60 days.

Eligible Conditions

Alzheimer's Disease
Healthy Adults

"MAD" Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ a 42-day follow-up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~a 42-day follow-up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and a 42-day follow-up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with serious AEs, TEAEs that lead to premature discontinuation, abnormal laboratory test results, abnormal ECG readings.

Secondary outcome measures

Maximum Tolerated Dose of AL001 in healthy subjects and patients with Alzheimers Disease

"MAD" Trial Design

5Treatment groups

Experimental Treatment

Group I: Multiple Ascending Doses of AL001 vs. Placebo - Cohort 5Experimental Treatment2 Interventions

The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 5 will be sub-divided into 2 cohorts: Cohort 5a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults) and Cohort 5b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 5a and 5b: 200% of 450 mg lithium carbonate equivalent of AL001 (6300 mg AL001 daily × 14 days - lithium dose equivalent to that used for bipolar/affective disorders, given as 10 × 210 mg AL001 capsules TID)

Group II: Multiple Ascending Doses of AL001 vs. Placebo - Cohort 4Experimental Treatment2 Interventions

The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 4 will be sub-divided into 2 cohorts: Cohort 4a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults) and Cohort 4b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 4a and 4b: 160% of 450 mg lithium carbonate equivalent of AL001 (5040 mg AL001 daily × 14 days, given as 8 × 210 mg AL001 capsules TID)

Group III: Multiple Ascending Doses of AL001 vs. Placebo - Cohort 3Experimental Treatment2 Interventions

The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 3 will be sub-divided into 2 cohorts: Cohort 3a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults) and Cohort 3b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 3a and 3b: 140% of 450 mg lithium carbonate equivalent of AL001 (4410 mg AL001 daily × 14 days, given as 7 × 210 mg AL001 capsules TID)

Group IV: Multiple Ascending Doses of AL001 vs. Placebo - Cohort 2Experimental Treatment2 Interventions

The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 2 will be sub-divided into 2 cohorts: Cohort 2a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults) and Cohort 2b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 2a and 2b: 100% 450 mg lithium carbonate equivalent of AL001 (3150 mg AL001 daily × 14 days, given as 5 × 210 mg AL001 capsules TID).

Group V: Multiple Ascending Doses of AL001 vs. Placebo - Cohort 1Experimental Treatment2 Interventions

Participants will be randomized to receive AL001. When adequate safety data are available, a review will be done for all participants to make a dose-escalation or dose and/or regimen modification decision. This will be repeated for each cohort. A total of 9 cohorts will receive 5 different dose levels of AL001 in multiple ascending doses under fasted conditions up to tolerability/safety limits. Cohort 1 will include 8 AD subjects. In this cohort, 6 active and 2 placebo AD subjects (as per randomization code) will receive the following treatment or placebo: • Cohort 1: 60% of 450 mg lithium carbonate equivalent of AL001 (1890 mg AL001 daily ×14 days, given as 3 × 210 mg AL001 capsules TID)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AL 001

2022

Completed Phase 2

~70

Placebo

1995

Completed Phase 3

~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alzamend Neuro, Inc.Lead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this clinical trial be beneficial for patients who are elderly?

"The target population for recruitment in this trial are patients that fall between the age of 50 to 80 years old."

Answered by AI

If I enroll, am I able to complete the whole clinical trial?

"Eligible individuals for this clinical study must have been diagnosed with alzheimer disease, and be between the ages of 50 to 80. This research project is looking to enroll around 72 patients in total."

Answered by AI

Are there any available slots in this research project for new volunteers?

"This clinical trial is recruiting patients at present, as reported on clinicaltrials.gov. The original posting date for this trial was May 4th, 2022 and it was last edited on November 4th, 2022."

Answered by AI

How many people can be in this clinical trial at one time?

"Yes, this is an active clinical trial that was posted on 5/4/2022 and updated as recently as 11/4/2022. The listing on clinicaltrials.gov shows that the study is enrolling 72 patients from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

2022. "Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363293.