Clinical trial: Study of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease (NCT04749563)

Eligibility criteria:
Inclusion Criteria:

          1. Patient and/or study partner (relative) must provide a signed and dated Informed
             Consent form prior to any study procedures which will be discussed with the Study
             Coordinator.

          2. Provision of a letter from the Neurologist/Psychiatrist/Internal Medicine Physician
             certifying the diagnosis of Alzheimer's Dementia and patient's ability to consent. If
             patient is unable to consent, only the legal guardian/tutor of the patient could
             consent in his/her behalf. The guardian/tutor will be required to present the
             pertinent legal documentation.

          3. Must have a study partner who is able and willing to comply with all required study
             procedures.

          4. Patient should meet NIA-AA criteria for Alzheimer's disease, any stage.

          5. At least 3 months evolution of behavioral symptoms at screening visit.

          6. Negative drug screen, except for benzodiazepines if patient has been using them in
             stable doses for at least 3 months before screening.

          7. All medications used for behavioral symptoms should be in stable doses for at least 3
             months before screening.

          8. All medications used for other conditions besides behavioral symptoms should be at
             stable doses for at least 30 days before screening.

          9. Women must be postmenopausal (defined as cessation of menses for at least 1 year) or
             surgically sterile (hysterectomy, oophorectomy or bilateral tubal ligation) at the
             time of screening.

        Exclusion Criteria:

          1. Prior adverse reaction to cannabinoids.

          2. Prior contraindication or allergy to any component of study product (IGC-AD1):
             melatonin, honey, curcumin, ethyl alcohol, vitamin-E TPGS, ascorbic acid, water,
             tween-80, and rutin.

          3. History of stroke, multiple sclerosis (MS), or epilepsy. History of gastrointestinal
             dysfunction not related to Alzheimer's disease (e.g., inflammatory bowel disease or
             gastrointestinal cancer)

          4. Any clinically relevant neurological disorder capable of producing a dementia syndrome
             including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies,
             frontotemporal dementia, and others.

          5. Other possible causes of dementia as: infections of the CNS (e.g. HIV, syphilis) or
             Creutzfeldt Jakob disease, subdural hematoma, communicating hydrocephalus, brain
             tumors, drug intoxication, alcohol intoxication, thyroid disease, parathyroid disease,
             and vitamin B12 or other deficiencies

          6. Use of contraindicated medication (see section 6).

          7. History of myocardial infarction, severe congestive heart failure, unstable angina,
             significant valvular disease, or cardiomyopathy within 1 year of screening.

          8. History of cardiac arrhythmias, second or third-degree AV block.

          9. History of seizures, schizophrenia, or bipolar disorder.

         10. Other condition or clinically important abnormality on vital signs, physical
             examination, neurologic examination, laboratory results or electrocardiogram (ECG)
             examination that could compromise the study efficacy interpretation or safety of the
             subject.

         11. Have participated in an investigational drug or device study within 30 days prior to
             study start.

         12. TCA or opioid use within 30 days before the enrollment.

         13. History of alcohol and drug abuse within 2 years of screening.

         14. Elevated liver enzymes (AST or ALT ≥3 times upper limit of normal, Total bilirubin≥1.5
             times ULN or ALP≥1.5 times ULN).

         15. Urine drug screen positive for drug use, except for benzodiazepines if patient was
             using them previously and their dose had remained stable for at least 3 months before
             screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment