Hope For Alzheimer's patients
and Caregivers
An exciting new clinical trial is evaluating an
investigational treatment for agitation in Alzheimer's
What Are The Symptoms of Agitation ?
Physical aggression:
e.g., hitting, kicking, biting.
Pacing or aimless wandering:
Repetitive actions or movements (e.g., tapping, fidgeting, rocking).
Verbal outbursts or aggression:
e.g., yelling, cursing, whining.
Destructive behavior:
e.g., earing objects, throwing things, hoarding.
Excessive demands for attention or help.
Restlessness or inability to stay still
What is Agitation in Alzheimer's?
CALMA is a multicenter Phase 2 clinical trial designed to evaluate the safety and efficacy of IGC-AD1 for treating agitation associated with Alzheimer’s dementia.
FDA Registered Trial
Clinical Trial Identifier: NCT 05543681
Clinicaltrials.gov:
https://clinicaltrials.gov/study/NCT05543681
Diagnosis of Alzheimer’s Disease.
Symptoms of agitation, aggression, irritability, or restlessness.
Regular behavioral medications are permitted before and during the study.
Have a caregiver who maintains daily contact with the study participant and commits to complying with the study procedures.
- No cost to participate in the CALMA trial
- We cover your expenses*
- Minimal time commitment- Only three clinic visits
- Receive a blood pressure monitor and weighing scale at no cost
- A dedicated care team supporting you every step of the way
Take part in groundbreaking research while receiving expert support
- Up to $500
Information for Families and Caregivers
(Download English)
Información para Familias y Cuidadores
(Descargar Español)
- Assess the efficacy of IGC-AD1 on cognition at Week 6.
- Measure changes in caregiver burden.
- Safety and Tolerability
- Analyze the biomarker panel.
- Daily Logbook with vitals.
In Clinic
Three visits
Safety Calls
Daily for the first three days. Afterwards every third day to review safety and compliance.
Please expect an email from our team, we will reach out to you shortly.
📩 Have questions? Contact us at calma@igcpharma.com
We look forward to your participation in the trial
Find the nearest partner clinic Enter zip code or your address to identify a clinical site near you
The CALMA Trial is a clinical research study evaluating an investigational medication for people living with Alzheimer’s disease who are experiencing symptoms of agitation or aggression, which can occur at different stages of the disease and are often very challenging for both patients and caregivers. The goal is to see whether this new medication can safely and effectively help reduce those symptoms.
The study drug is safe and tolerable. Still, during phase 1 there were some symptoms reported,
- Mild and temporary dizziness that resolves on its own.
- Drowsiness (somnolence)
- Lack of energy
- Falls
- Nausea
Yes, this study will cover transportation services; it could be uber or paying for parking. Also we provide a meal, as the medical visit takes time, (each appointment could take up to 3-4 hours.)
There will be no charges for participation in this study. The study drug, study related procedures, and study visits will be provided at no cost to you or your insurance company (it is not necessary that you have insurance, and if you have it, there is no issue with it ).
The total study time is expected to be about 50-57 days or about 8 weeks (including pre-screening, screening, evaluation, study treatment, and follow-up).
In this study, the participant will be required to take two doses of the study drug daily. However, before starting with the full dose, the participant will take a smaller dose on each of the first two days and on the third day you will take the full dose. Always during the study there will be clear indications on how to proceed.
Participation in another clinical trial may affect eligibility for this one. We would need to know more details about the other study to determine whether there’s a potential conflict.
Yes, the medication being studied is new and considered investigational. The study drug is an oral solution. It contains two active ingredients, tetrahydrocannabinol (THC) and melatonin.
You can blend it only with water.
A placebo is a substance that looks like real medication but doesn’t contain any active ingredients. It’s used in clinical trials to help researchers compare and understand the true effects of the investigational drug.
We work with clinics in several areas. With your zip code or city you can explore in our website the closest clinic.