Your session is about to expire
← Back to Search
Cannabinoid
THC-Based Medication for Agitation in Alzheimer's (IGC-AD1-P2 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
Awards & highlights
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
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 moreTrial 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.
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.
Find a Location
Who is running the clinical trial?
IGC Pharma LLCLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Dr Ismael Toro Grajales, MDPrincipal InvestigatorInstituto Sanacoop
Natalia HernandezStudy DirectorInstituto Sanacoop
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses that could affect the trial's safety assessment.My medications for behavioral symptoms have been stable for 3 months.I have a history of seizures, schizophrenia, or bipolar disorder.I have long-term severe agitation not caused by another health issue.I do not have uncontrolled high blood pressure or a recent severe increase in blood pressure.I have not had allergic reactions to cannabinoids or ingredients in the study drug.I tested positive for drugs, but I've been on a stable dose of benzodiazepines for over 3 months.I agree to genetic testing for medication metabolism.I have fallen more than twice in the last 6 months, some causing injury or during an illness.I am a woman who cannot become pregnant (either through menopause or surgery).You have significant agitation based on a specific assessment tool called the Neuropsychiatric Inventory (NPI), with a score of 4 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Active Comparator: IGC-AD1Active
- Group 2: Placebo Comparator: IGC-AD1 Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger