Clinical Trial on Agitation in Alzheimer's Dementia (NCT05543681) | Clinical Trial Compass
RecruitingPhase 2
Clinical Trial on Agitation in Alzheimer's Dementia
United States, Canada, Colombia164 participantsStarted 2022-10-11
Plain-language summary
The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures.
. Must have a Caregiver who is able and willing to comply with all required study procedures.
. 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.
. 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.
. Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.
. Diagnosis of AD by NIA-AA criteria
. Clinically significant Agitation assessed by:
. NPI (Agitation) ≥ 4
Exclusion criteria
. Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial for agitation in Alzheimer's disease — what does that mean for how much is already known about whether the treatment is safe and effective at this stage?
2Since the trial is specifically focused on agitation and aggression in Alzheimer's, how does my loved one's current level of agitation compare to what this study seems to be targeting, and would they likely fit the profile of participants being enrolled?
3Are there already approved medications or non-drug approaches for managing agitation in Alzheimer's that we should consider trying first before looking at an experimental Phase 2 study?
4The trial also mentions caregiver burden as a condition it's addressing — does that mean there's a component that supports or involves me as a caregiver, and how would that affect our day-to-day life if we participated?
5Given that this trial is still actively recruiting, what would the timeline and visit schedule look like, and is that realistic given our current situation with managing Alzheimer's care at home?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.
. History of seizures, schizophrenia, or bipolar disorder.
. Has participated in an investigational drug or device study within 30 days prior to study start.
. 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.
. History of Alcohol and Drug use disorder, within one year prior to enrollment.
. 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.
. 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).