Phase 2 Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 55 and 85 years old who are able to give informed consent to participate.
• People who have been diagnosed with Mild Cognitive Impairment (a condition involving noticeable memory or thinking changes that are milder than dementia) by a clinician, or who have symptoms of this condition as assessed by the study doctor.
• People who score 8 or lower on a questionnaire about everyday activities (the FAQ) and who report being able to manage daily life independently.
• People who score 25 or below on a standard memory and thinking test called the Montreal Cognitive Assessment (MoCA).
• People who score either 0.5 or 1 on the Clinical Dementia Rating (CDR) scale, which is a tool used to measure the severity of memory and thinking difficulties.
• People who have a family member, friend, or carer who is willing and able to participate in phone-based assessments throughout the full 24-week study, with the same person available for all such calls.
• People who are able to demonstrate that they understand what the study involves before joining.
• People who are interested in using CBD as a possible support for cognitive function.
• People who plan to remain living in the Denver, Colorado metro area for the next 6 months.
• People who are able to attend in-person visits at the study location.

Who may not be able to join:

• People who have another brain or nervous system condition (such as Parkinson's disease or multiple sclerosis) that is expected to affect memory or thinking.
• People who have had a brain injury that is currently causing memory or thinking problems (for example, a concussion involving significant loss of consciousness).
• People who have a serious or unstable physical health condition.
• People who are currently taking medications for Parkinson's disease, antipsychotics, anti-seizure medications, or a type of medication called anticholinergics.
• People who have ever been diagnosed with schizophrenia, a psychotic disorder, bipolar disorder (type I or II), certain personality disorders (antisocial, borderline, narcissistic, or histrionic), or an eating disorder, as defined by standard psychiatric guidelines.
• People who are already taking part in other clinical studies that involve memory and thinking tests more than once a year.
• People who have used cocaine, opioids, methamphetamine, or MDMA in the past 60 days, or who test positive for these substances at the start of the study.
• People who report using more than 150mg per week of cannabis edible products.
• People who report using more than 7 grams per week of cannabis flower products (not including CBD products).
• People who have a recent history of, or currently meet the criteria for, major depression with thoughts of suicide.
• People who are currently using medical CBD products.
• People whose liver enzyme levels (AST or ALT) are more than twice the normal range.
• People who are currently taking certain medications that are known to interact with Epidiolex (the CBD product being studied), including clobazam, lamotrigine, valproate, buprenorphine, sodium oxybate, and several others (confirm full list with the trial site).
• People who are pregnant at the time of enrolment, or who are not yet post-menopausal and are unwilling to use contraception for the duration of the study.
• People whose mild cognitive impairment may be caused by a treatable condition, such as an underactive thyroid or vitamin B12 deficiency.

Important: Always verify eligibility with the trial site directly before applying.