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RecruitingAlzheimer DiseaseDementiaMajor Neurocognitive Disorder With Aggressive Behavior

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease

Eligible age

50–90 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants' quality of life.

Sponsor: Eastern Virginia Medical School

You may qualify if…

  • ✓ Males/females over 50 years old.
  • ✓ Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.
  • ✓ A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive.
  • ✓ Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation/aggression subscore \> 3.
  • ✓ Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent.
  • ✓ For patients treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEI) and/or memantine), the dosage must be stable for at least 1 month (30 days). If the ChEI and/or memantine has been discontinued, patients may enroll after 15 days.
  • ✓ Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them.

You may not qualify if…

  • ✕ Diagnosis of non-AD or non-mixed dementias.
  • ✕ Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4).
  • ✕ NPI-agitation-aggression score \< 3.
  • ✕ Having a serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease which might confound assessment of safety outcomes as determined by the study physician.
  • ✕ Presence or history of other serious psychiatric disorders or neurological conditions (e.g. psychotic disorders, bipolar disorder or schizophrenia).
  • ✕ Current abuse of/dependence on marijuana, current drug abuse, current alcohol abuse.
  • ✕ Having seizure disorders.
  • ✕ Pregnant or breastfeeding

Where it's recruiting

Virginia

Norfolk

Source: ClinicalTrials.gov · NCT04436081 · last updated 2023-02-16