Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could cannabis calm Alzheimer's agitation? new trial underway

NCT ID NCT05543681

Symptom relief Sponsor: IGC Pharma, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether IGC-AD1, a THC-based oral medication, can safely reduce agitation in people with mild to severe Alzheimer's dementia. About 164 participants will receive either the drug or a placebo twice daily for several weeks. Researchers will measure changes in agitation using a standard scale, aiming to improve quality of life for patients and their caregivers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IGC-AD1 (a THC-based oral solution)
What this could lead to
If it works, this could offer a new way to calm agitation in people with Alzheimer's, potentially reducing caregiver burden.
What could go wrong
This is an early Phase 2 trial with only 164 participants, so results may not apply to everyone. The drug contains THC, which can cause side effects like dizziness or confusion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aggression are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Aggression Alzheimer disease anxiety disorder cannabis dependence Caregiver Burden dementia Depression nail-patella syndrome Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aggression Agitation,psychomotor Alzheimer disease Care giving burden NPS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BayCare Health System Inc.

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Baycrest Academy for Research and Education , University of Toronto

    RECRUITING

    Toronto, Ontario, ON M6A 2E1, Canada

  • Baylor Scott and White Research Institute

    RECRUITING

    Dallas, Texas, 75231, United States

  • Butler Hospital, Brown University

    RECRUITING

    Providence, Rhode Island, 02906, United States

  • Central Miami Medical Institute

    RECRUITING

    Miami, Florida, 33125, United States

  • ClinCloud, LLC

    ACTIVE_NOT_RECRUITING

    Maitland, Florida, 32751, United States

  • ClinCloud, LLC

    RECRUITING

    Melbourne, Florida, 32940, United States

  • Dent Neurologic Institute

    RECRUITING

    Amherst, New York, 02459, United States

  • Dominion Medical Associates, Inc.

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Douglas Hospital Research Center, McGill university

    RECRUITING

    Montreal, Quebec, H4H 1R3, Canada

  • Grupo de Neurociencias de Antioquia, Universidad de Antioquia

    ACTIVE_NOT_RECRUITING

    Medellín, Antioquia, Colombia

  • Hamilton Health Sciences , Mcmaster University

    RECRUITING

    Hamilton, Ontario, L8M 1W9, Canada

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Ichor Research

    RECRUITING

    Syracuse, New York, 13210, United States

  • Instituto Sanacoop

    COMPLETED

    Bayamón, Bayamón, 00961, Puerto Rico

  • Integrative Clinical Trials, LLC

    RECRUITING

    Brooklyn, New York, 11229, United States

  • Island Health Authorities

    RECRUITING

    Victoria, British Columbia, V8R 1J8, Canada

  • Kerwin Medical Center

    RECRUITING

    Dallas, Texas, 75231, United States

  • Lynn Health Science Institute (LHSI)

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • MedStar Franklin Square Medical Center Neurology

    RECRUITING

    Baltimore, Maryland, 21237, United States

  • Medstar Montgomery Medical Center

    RECRUITING

    Olney, Maryland, 20832, United States

  • Medstar Southern Maryland Hospital Center

    RECRUITING

    Clinton, Maryland, 20735, United States

  • Miami Jewish Health

    RECRUITING

    Miami, Florida, 33137, United States

  • Neurostudies Inc.

    RECRUITING

    Port Charlotte, Florida, 33952, United States

  • SCB Research Center Corp

    RECRUITING

    Bayamón, 00961, Puerto Rico

  • Senior Adults Specialty Research

    RECRUITING

    Austin, Texas, 78757, United States

  • Tandem Clinical Research GI, LLC

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Tekton Research LLC

    RECRUITING

    St Louis, Missouri, 63128, United States

  • The Alliance, Medical Sciences Campus University of Puerto Rico

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • University of South Florida Department of Psychiatry and Behavioral Neurosciences

    RECRUITING

    Tampa, Florida, 33613, United States

  • Visionary Investigators Network

    RECRUITING

    Miami, Florida, 33133, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.