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Treatment for agitation in Alzheimer's dementia using THC and melatonin

A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants With Dementia Due to Alzheimer's Disease

Phase 2 Interventional IGC Pharma, LLC · NCT05543681

This study is testing if a new medication combining THC and melatonin can help reduce agitation in older adults with Alzheimer's dementia.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment164 (estimated)
Ages60 Years and up
SexAll
SponsorIGC Pharma, LLC Industry-sponsored
Locations30 sites (Maitland, Florida and 29 other locations)
Trial IDNCT05543681 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of IGC-AD1, an oral medication containing THC and melatonin, in reducing agitation in patients with mild to severe Alzheimer's dementia. Participants aged 60 and older who have shown significant agitation for at least two weeks will be enrolled in a multi-center, double-blind, randomized, placebo-controlled design. The treatment lasts for 42 days, with safety monitored through regular check-ins and assessments of agitation using the Cohen-Mansfield Agitation Inventory. Blood samples will also be collected for pharmacokinetic analysis during the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older diagnosed with mild to severe Alzheimer's dementia who exhibit clinically significant agitation.

Not a fit: Patients with agitation due to conditions other than Alzheimer's dementia or those with transient symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce agitation in Alzheimer's patients, improving their quality of life and easing caregiver burden.

How similar studies have performed: While the use of THC for agitation in dementia is a novel approach, other studies exploring cannabinoid treatments for various conditions have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
To be eligible to participate in this study, the participant must meet all the following criteria:

Inclusion Criteria

1. Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures.
2. Must have a Caregiver who is able and willing to comply with all required study procedures.
3. The Caregiver must be known to the Participant and must be able to use electronic devices such as a cell phone, video conference over a laptop or cell phone, weighing scale, and be able to learn to take blood pressure, among others.
4. Based on local practice, Participants that cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney, b) is a spouse, or c) a sibling or d) a child or e) a close relation. The practice of accepting consent must be consistent with established practice at the site and jurisdiction.
5. Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.
6. Diagnosis of AD by NIA-AA criteria
7. Clinically significant Agitation assessed by:

   1. NPI (Agitation) ≥ 4
   2. The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and
   3. Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.
8. Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.
9. All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.
10. Women must be of no childbearing potential (postmenopausal, defined as cessation of menses for at least 12 months, without an alternative medical cause for amenorrhea) or surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)).

An individual who meets any of the following criteria will be excluded from participation in this study:

Exclusion Criteria

1. Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
2. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.
3. History of seizures, schizophrenia, or bipolar disorder.
4. Has participated in an investigational drug or device study within 30 days prior to study start.
5. Urine drug screen positive for drug use, except for benzodiazepines if Participant was using them previously and their dose had remained stable for at least six weeks before screening.
6. History of Alcohol and Drug use disorder, within one year prior to enrollment.
7. Hypertension: Participants with a history of uncontrolled hypertension as determined by the PI and Participants with a hypertensive crisis in the six months prior to enrollment.
8. Falls: Participants with a history of recurrent falls defined as more than two falls in the six-month period prior to enrollment and a history of falls resulting in injuries or associated with a new acute illness, loss of consciousness, fever, or abnormal blood pressure (Fuller et al., 2000).

Where this trial is running

Maitland, Florida and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer DiseaseAgitation,PsychomotorCare Giving BurdenNPSAggressionCannabisTetrahydrocannabinolTHC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.