Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic Study of AL001 in Patients With Alzheimer's Disease

• Status: Not yet recruiting
• Trial end date: 2023-04-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alzamend Neuro, Inc.

Criteria

Inclusion Criteria:

• 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

• Males (non-vasectomized and vasectomized) must agree to use barrier contraception during the study until after Study Day 42

• Females must meet criteria if childbearing for contraception or be non-childbearing

• Clinical diagnosis of dementia (neurocognitive disorder) by a qualified clinician based on the DSM-V criteria:

• Considered AD Stage 2, 3, or 4 based on the FDA classification

• Mini-Mental State Examination (MMSE) score between 16 and 26, inclusive, at Screening

• Patient's health is judged adequate to participate in this clinical study by the Investigator

Exclusion Criteria:

• Female who is breastfeeding, pregnant, planning to become pregnant during study

• Kidney disease (eGFR <50 mL/minute/1.73 m2)

• History of untreated thyroid dysfunction that may be independently associated with cognitive impairment

• Uncontrolled tachy/brady arrhythmias, atrial fibrillation or coronary heart failure

• Any medical condition that in the Investigator's judgement would affect patient safety and scientific integrity of the studySystemic related exclusions:

• History of allergy or AE(s) associated with the study treatments, including lithium and salicylates

• Pre-existing peptic ulcer, hemorrhagic gastritis, or duodenitis

• Magnetic resonance imaging (MRI)-related exclusion criteria

• Treatment with haloperidol

• Hyponatremia

• Suspected of having or at risk for Brugada Syndrome

• Prescribed or over-the-counter use of a salicylate-containing product other than low dose aspirin for cardioprotection (eg, aspirin, bismuth sub-salicylate, salicylazosulfapyridine [sulfasalazine]) from 1 week before first dose to 1 week after last dosing; treatment with haloperidol

• Aspirin/nasal polyposis/asthma syndrome