CompletedPhase 1/2

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

United States, Canada65 participantsStarted 2022-05-04

Plain-language 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.

Who can participate

Age range50 Years – 80 Years

SexALL

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Exclusion criteria

✕. any medical condition that (per investigator's judgement) would affect subject safety and scientific integrity of the study, e.g., untreated hypothyroidism (TSH \>10 mIU/L) or vitamin B12 deficiency (\<300 pg/mL) which may contribute to cognitive impairment, delirium, non-AD dementia and other encephalopathies
✕. Hachinski scale score \>4 or evidence of stroke within the past 5 years
✕. Active cancer (except squamous cell and basal skin cancers) requiring chemo- or radiation therapy
✕. Positive test results for HIV, HBV, and HCV (unless quantitative PCR negative for HCV) at Screening
✕. Uncontrolled hypertension with a sustained blood pressure \>160/100 mmHg at Screening, check-in (Day -1), and prior to the first study drug administration
✕. Fever (body temperature \>101.4°F \[38.5°C\]), acute upper respiratory, or any other infections at Screening, check-in (Day -1), and prior to the first study drug administration

What they're measuring

Number of Participants With Serious AEs, TEAEs That Lead to Premature Discontinuation, Abnormal Laboratory Test Results, Abnormal ECG Readings.

Timeframe: 42 days with a 14-day treatment period

Trial details

NCT IDNCT05363293

SponsorAlzamend Neuro, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-14

Results submitted2024-12-09

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