From Telecom to THC: How an Engineer Tackled Alzheimer's Agitation

Ram Mukunda has never done a podcast before. But when the CEO of IGC Pharma settles into the conversation, what emerges is a journey that spans four decades—from electrical engineering at the University of Maryland to telecommunications empires to the thorniest recruitment challenges in Alzheimer’s trials.

“You know, quite honestly, I’ve never done a podcast,” Mukunda admits at the start. What follows is the story of how an engineer with a biomedical engineering background came full circle to attack one of dementia’s most devastating symptoms: agitation.

The Banking Problem Nobody Talks About

Mukunda’s path into Alzheimer’s wasn’t straightforward. After founding Startec Global Communications and taking it public on NASDAQ in 1997, he started IGC looking at cannabis infrastructure. The company couldn’t build facilities for marijuana operations as a public entity, so they pivoted to the medical potential of cannabinoids.

“We’ve had our bank accounts closed by at least seven or eight banks,” Mukunda reveals. Even with IGC-AD1 derived from hemp (federally legal under the 2018 Farm Bill with THC below 0.3%), the banking stigma persists.

“Bankers really need to look at hemp versus marijuana,” he explains. “The 2018 Farm Bill clearly draws the line. Anything on this side is hemp and is federally legal. But that distinction is just completely lost.”

It’s a regulatory reality that shapes everything from trial financing to shareholder deposits. The NYSE American doesn’t list marijuana companies—yet IGC still faces banking restrictions.

The Ultra-Low Dose Discovery

The scientific foundation came from Dr. Chuanhai Cao at the University of South Florida, who had spent seven years studying THC in Alzheimer’s models. His research showed that ultra-low doses of THC behave differently than high doses.

IGC licensed the technology and developed IGC-AD1: an ultra-low dose THC formulation combined with melatonin. One milliliter—a single dropper—taken daily.

“If you were to give the patient a higher dose, you’re talking about people that are 80 years old—they could get high, they’re going to fall, break a hip. Very high risk of falls,” Mukunda explains. The synergy between compounds keeps both at safe levels for elderly patients.

When Phase 1 Revealed an Unexpected Signal

Phase 1 established safety at three different dosing frequencies. But the trial also captured neuropsychiatric symptom data.

“Initially we thought this is something that could actually help patients that have Alzheimer’s removing plaque, helping the neurons,” Mukunda recalls. “But when we took this to Phase 1, we also looked at neuropsychiatric symptoms that are associated with Alzheimer’s. We looked at anxiety, agitation, depression, irritability, sleep disorders.”

That’s when the agitation signal emerged.

“What we found was that our medication was able to reduce agitation and make the patient a lot more manageable without completely sedating them and having them just lie on a sofa all day.”

Agitation affects up to 76% of Alzheimer’s patients. Mukunda describes the clinical manifestations: “Verbally agitated—shouting, yelling, screaming. Physical agitation—throwing things, hitting people, biting people. There’s also pacing, motor movements like opening and closing a drawer constantly, wandering—leaving the house, trying to get out, opening locks and just leaving.”

The caregiver burden is substantial. “You try and feed a patient and they throw the food away or throw it at you or accuse you of trying to poison the individual. It’s very difficult. It leads to separation of families. Families have to end up putting the person in a nursing home or getting help which is very expensive.”

The clinical cascade: “This agitation also leads to an acceleration of cognitive decline. Increased medications, acceleration of cognitive decline, separation of families, expenses.”

Current options are limited. “The individual is dosed with antipsychotics or medications that just sedate the patient. There’s really no other way of dealing with this currently.”

The Phase 2 Trial Design

IGC launched their Phase 2 trial (now named CALMA - Calming Agitation in Alzheimer’s) across multiple sites in the US and Canada. Mukunda describes the operational challenges:

“When we have a trial for agitation, we’re looking for a patient that is not completely sedated, lives at home with a caregiver, and is someone that can come to the clinic three or four times maximum. You come in at baseline, week two, week four, week six. Week four is optional, can even be over video.”

The inclusion criteria create recruitment complexity: “Highly agitated, has had agitation for a period of two weeks at least, is on some stable medication. It’s difficult because if we were just doing Alzheimer’s patients, it would be a little bit easier, not a whole lot. But when you’re looking specifically for agitation, it’s a little bit hard.”

The trial requires substantial caregiver involvement. “Typically the patient really isn’t in a position to say ‘I’m agitated, I want to join this trial’—it’s the caregiver, so we have to have a conversation with the caregiver.”

IGC hired five healthcare-focused interns for pre-screening. “We hired interns that are very compassionate, they’re in healthcare, they want to go to medical school or get a master’s in public health. We advertise, we have videos running on Facebook explaining agitation, what our trial is. Someone sees the video, fills out a form, and our group calls them and explains what the trial is, explains how many visits there are, what is expected.”

Managing expectations is critical: “There’s a 50% chance that you’re going to get the medication. Half of the patients get placebo. We’re trying to introduce an open-label at the end of the trial so that everyone gets the medication.”

The Recruitment Innovation That Scaled

After struggling with traditional approaches, IGC implemented geofencing technology—digitally targeting individuals within a 15-25 mile radius of clinical sites with social media ads.

According to company announcements, the strategy was piloted at select sites where it achieved a 200-300% increase in enrollment at relatively low cost per lead. IGC then scaled this across all trial locations in the US and Canada.

“Recruitment is one of the most significant challenges in Alzheimer’s clinical trials,” Mukunda acknowledges. “We do Facebook ads and that’s starting to work.”

The Interim Phase 2 Data

Mukunda describes the interim findings: “What we’ve discovered is compared to the existing medication, our medication can work very quickly. The existing antipsychotics take about 6 weeks to build up in your system before they can start working. Ours works—we have very clean data that shows that it works in two weeks, but it even works significantly faster than that.”

Published interim data showed meaningful reductions in agitation at both week two and week six on the Cohen-Mansfield Agitation Inventory.

Sleep improvements also emerged. “We’ve noticed that our medication is amazing at allowing the patient to actually get a good night’s rest. The number of sleep disturbances in the patient reduces.” Company data showed a 71% reduction in sleep disturbances by week two, climbing to 78% by week six.

Navigating Regulatory Requirements

Despite both components being individually well-characterized, Mukunda notes the regulatory path for the combination: “Even though they’ve been studied individually, we still have to go through all of this. We have to do tox studies for melatonin, prove to the FDA that at even at this dosing it’s safe when it’s taken over time, and prove that the combination is safe.”

The AI Diagnostic Initiative

Beyond the agitation trial, Mukunda describes a parallel diagnostic initiative targeting early detection.

“There are 400 million people with plaque built up in their brains. To diagnose them you need a PET scan, which a lot of people don’t have access to. They go to doctors who are general practitioners who may not recognize all the symptoms, so there’s a very high level of false negatives. The caregiver walks in: ‘My mom forgets stuff, she wanders.’ The general practitioner says, ‘Oh, it’s part of aging, this is normal, nothing we can do.’”

IGC is developing an AI model using data from multiple databases: “We’re taking data from 100 different databases from about 20 different countries and we’re developing a foundation AI model that can help a doctor diagnose the patient. It’s a physician’s tool.”

The model accepts multiple input types: “The doctor inputs information about the patient—where the patient lives, demographics, family history, diet, even things like too much sugar in the diet. The model will stratify the individual and tell the doctor this person is at low risk of Alzheimer’s or moderate or high risk, and give a score as to what will happen over the next two to three years.”

His rationale focuses on intervention opportunity: “There are things you can do. 40% of dementia can be delayed. Exercise, diet, social interaction, cardiovascular health—if you’ve got cardiovascular issues, diabetes, something can be done. There are steps you can take to prevent, to delay, to improve. The whole idea is if you can delay five years, medication will come along.”

What Clinical Operations Teams Should Watch

Geofenced recruitment addresses caregiver dynamics – When patients cannot self-advocate, targeting caregivers within driving distance of sites with symptom-specific messaging drove 200-300% enrollment increases at pilot sites.

Compassionate pre-screening infrastructure matters – Healthcare-focused interns provided the empathy needed to explain trial logistics, manage placebo expectations, and support overwhelmed caregivers.

Speed-to-effect has retention implications – Two-week onset versus six-week antipsychotic buildup may improve caregiver satisfaction and influence retention rates.

Hemp-derived compounds face banking friction – Despite federal legality, THC-containing products create ongoing operational challenges including account closures and investor restrictions.

Symptom-specific trials are operationally complex – Finding agitated but non-sedated patients with committed caregivers requires different infrastructure than general Alzheimer’s trials.

The full CALMA trial results will determine whether IGC-AD1’s interim signals translate to meaningful clinical benefit. But Mukunda’s journey illustrates how operational execution—recruitment innovation, regulatory navigation, caregiver engagement—shapes trial outcomes independent of pharmacology.

For a first podcast, he covered territory that clinical operations professionals recognize: the complicated reality of symptom-specific trials, caregiver-dependent recruitment, and navigating regulatory frameworks that don’t always align with scientific logic.

Brandon Li is Co-Founder at Power, where we’ve accelerated patient recruitment timelines across neuropsychiatry and other therapeutic areas for the past 4 years.