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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 weeks two and six
Awards & highlights
IGC-AD1-P2 Trial Summary
This trial looks at the effect of a THC-based medication on symptoms of agitation in people with Alzheimer's.
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.Check my eligibility
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.See study design
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.
IGC-AD1-P2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week six
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week six
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Agitation
Secondary outcome measures
Acute Agitation
Other outcome measures
Agitation at week four
CYP2C9 polymorphisms on agitation
Caregiver burden
+6 moreIGC-AD1-P2 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals is the research team recruiting for this experiment?
"Confirmed. According to the information on clinicaltrials.gov, this research study began recruiting participants on October 11th 2022 and was recently updated February 7th 2023. 164 volunteers are sought from a single location in order to complete the trial."
Answered by AI
Has the FDA sanctioned Active for widespread use?
"Our assessment gave Active a rating of 2 on the safety scale, as this is only Phase 2 and there are no current studies regarding efficacy."
Answered by AI
Are there any opportunities currently available to partake in this research?
"Affirmative. According to clinicaltrials.gov, the research initiative launched on October 11th 2022 and is still open for recruitment as of February 7th 2023. 164 patients are needed at a single medical facility."
Answered by AI
Who else is applying?
What site did they apply to?
Sante Cannabis
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
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