NCT04749563

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

A Phase I Randomized Placebo Controlled MAD Study to Evaluate Safety and Tolerability of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: IGC Pharma, LLC · Industry
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Dementia of Alzheimer Type

Interventions

Type	Name	Description
DRUG	IGC AD1	IGC AD1 oral Solution
DRUG	Placebo	Placebo of IGC AD1 oral Solution

Timeline

• Start date: 2021-01-11
• Primary completion: 2021-06-20
• Completion: 2021-06-20
• First posted: 2021-02-11
• Last updated: 2022-09-16

Locations

1 site across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study