What side effects are associated with this type of intervention?

Common treatments for depression include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and THC-based formulations. SSRIs and SNRIs can cause side effects such as nausea, insomnia, dizziness, weight gain, and sexual dysfunction. THC-based treatments, like those studied in the IGC-AD1 trial, may cause sedation, dizziness, disorientation, and potential respiratory depression, especially when combined with other central nervous system depressants. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has not approved any THC-based formulations specifically for the treatment of depression. Traditional FDA-approved treatments for depression include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and atypical antidepressants. While cannabinoids like THC are being studied for various conditions, including agitation in dementia and chronic pain, their use in depression treatment remains experimental and is not yet FDA-approved.

What other types of research exist?

Promising alternatives to IGC-AD1 for treating depression in 2024 include cannabidiol (CBD), which has shown efficacy in reducing symptoms of anxiety and depression in clinical trials. Additionally, N-acetylcysteine (NAC) has demonstrated potential benefits in modulating glutamatergic and inflammatory pathways, which may be relevant for depression treatment. Both options have been well-tolerated in studies.

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Cannabinoid

THC-Based Medication for Agitation in Alzheimer's (CALMA Trial)

Phase 2

Recruiting

Led By Dr Ismael Toro Grajales, MD

Research Sponsored by IGC Pharma, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week six

Summary

This trial tests a natural THC-based medicine called IGC-AD1, given in small doses regularly. It targets people aged 60 and above with Alzheimer's-related dementia who have been experiencing agitation. The THC in the medicine helps reduce agitation by interacting with brain signals. The most recent trial reported significant improvement in agitation using nabilone.

Who is the study for?

This trial is for adults with mild to severe Alzheimer's dementia experiencing significant agitation. Participants must have a caregiver able to assist and use electronic devices, be on stable behavioral medications for 3 months, and consent to genetic testing. Women should not be of childbearing potential.

What is being tested?

The study tests IGC-AD1, a natural THC-based oral medication given in micro doses twice daily against a placebo, to manage symptoms of agitation in Alzheimer's patients.

What are the potential side effects?

Potential side effects may include typical reactions associated with THC such as drowsiness, changes in appetite or mood, dry mouth, and possibly disorientation or confusion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks two and six

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks two and six

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks two and six for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Agitation

Secondary study objectives

Acute Agitation

Other study objectives

Agitation at week four

CYP2C9 polymorphisms on agitation

Caregiver burden

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Comparator: IGC-AD1ActiveActive Control1 Intervention

IGC-AD1 Active Treatment THC plus another API plus excipients.

Group II: Placebo Comparator: IGC-AD1 PlaceboPlacebo Group1 Intervention

IGC-AD1 Placebo, similar to Active in color, taste, and texture, with excipients but without APIs.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and atypical antidepressants. SSRIs and SNRIs work by increasing the levels of serotonin and norepinephrine in the brain, which are neurotransmitters associated with mood regulation. Atypical antidepressants may target a variety of neurotransmitter systems, including dopamine. The THC-based formulation in the IGC-AD1 trial interacts with the endocannabinoid system, which plays a role in mood, stress response, and emotional regulation. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.