At a glance
ClinicalIndex Comparison Record- ✓Mild to moderate Alzheimer's disease, reasonably good physical health per investigator review
- ✓Clinical diagnosis of dementia (neurocognitive disorder) by qualified clinician based on DSM-V criteria
- ✓MMSE score 16–26 inclusive at screening
- ✓AD Stage 2, 3, or 4 per FDA classification
- ✕eGFR <60 mL/min/1.73 m² (kidney disease)
- ✕Uncontrolled tachycardia/bradycardia, atrial fibrillation, or coronary heart failure
- ✕Neuropsychiatric disorders other than AD: schizophrenia, psychotic syndromes, Parkinson's disease, myasthenia gravis, seizure disorder, or severe head trauma (except single childhood febrile seizure)
- ✕Depression except mild, asymptomatic, stable depression
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multiple-dose, Steady-state, Double-blind, Ascending Dose, Safety, Tolerability, Pharmacokinetic Study of AL001 in Patients With Mild to Moderate Alzheimer's Disease and Healthy Adult Subjects ("MAD Study")
In Brief
A Phase 2 clinical trial evaluating AL001 and Placebo for Alzheimer's Disease and Healthy Non-elderly and Elderly Adults. Completed, enrolled 65 participants across 2 sites in 2 countries.
Detailed Summary
This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Up to 72 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.
Study Details
Timeline
Interventions
a crystal engineered lithium-salicylate-proline lithium delivery product
matching placebo formulation