Testing IGC-AD1-Active against a placebo for alzheimer disease

Inclusion

• +Participant and/or Caregiver must provide a signed and dated ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 siteTrial siteA hospital or clinic where a study is actually run.Read more → and jurisdiction.
• +Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokineticsPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more →.
• +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• +All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.
• +An individual who meets any of the following criteria will be excluded from participation in this study:
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +Prior adverse reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → to cannabinoids or to any component of Study Drug (IGC-AD1 and placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →).
• +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• +Hypertension: Participants with a history of uncontrolled hypertension as determined by the PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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).
• +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)).