Study of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease

Status Completed

Clinical Trial Summary

A single center, randomized, placebo controlled multiple ascending dose study of IGC AD1 to evaluate safety and tolerability in subjects with dementia due to Alzheimer's Disease (AD).

Clinical Trial Description

This is a phase I Multiple Ascending Dose (MAD) study to evaluate safety and tolerability of IGC-AD1 in subjects with AD. Twelve subjects will be enrolled. Three different ascending doses of the study product will be given: low, medium and high doses. Each dose will be given for 2 weeks, followed by a washout period of 4 days. Given the vulnerability of the population, a safety cohort of 3 patients (2 active, 1 placebo) will start every dose one day ahead of the rest of the patients and will be followed for 24 hours for the development of Adverse Events (AEs). Objective criteria will be set after the safety cohort is evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04749563
Study type	Interventional
Source	India Globalization Capital Inc
Contact
Status	Completed
Phase	Phase 1
Start date	January 11, 2021
Completion date	June 20, 2021

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