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New treatment option for Alzheimer Disease
Official title Clinical Trial on Agitation in Alzheimer's Dementia
ClinicalTrials.gov ID: NCT05543681
What this study is testing
What is IGC-AD1-Active?
IGC-AD1-Active is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alzheimer disease.
Also referred to as Active.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well the medication IGC-AD1 helps reduce agitation in people with Alzheimer's dementia.
- Who it's for
- The study is looking for patients with mild to severe Alzheimer's dementia who experience agitation.
- What's involved
- Participants will take the medication IGC-AD1 twice a day and may have regular check-ins to monitor their condition.
- Time commitment
- The length of the study and the number of visits are not specified.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- To be eligible to participate in this study, the participant must meet all the following 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...
- Based on local practice, Participants that cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney...
You likely can't join if
- Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which...
- 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...
- History of Alcohol and Drug use disorder, within one year prior to enrollment.
See the full eligibility criteria
- To be eligible to participate in this study, the participant must meet all the following 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...
- 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...
- 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
- The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and
- Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.
- Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.
- All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.
- 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...
- Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Maitland, Florida, United States
- Melbourne, Florida, United States
- Miami, Florida, United States
- Port Charlotte, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Metairie, Louisiana, United States
- Baltimore, Maryland, United States
- Clinton, Maryland, United States
- Olney, Maryland, United States
- St Louis, Missouri, United States
- Amherst, New York, United States
- Brooklyn, New York, United States
- New York, New York, United States
- Syracuse, New York, United States
- Oklahoma City, Oklahoma, United States
- Providence, Rhode Island, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Richmond, Virginia, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maitland, Florida, United States; Melbourne, Florida, United States; Miami, Florida, United States; Port Charlotte, Florida, United States; St. Petersburg, Florida, United States; Tampa, Florida, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.