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Recruiting Phase 2

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

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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.

Condition
Alzheimer Disease, Dementia, Major Neurocognitive Disorder With Aggressive Behavior
Tested
THC-free CBD Oil, Placebo
Sponsor
Eastern Virginia Medical School

Who can join

Age
50 to 90 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 50 years
  • Maximum age: 90 years
  • Study condition: Alzheimer Disease, Dementia, Major Neurocognitive Disorder With Aggressive Behavior
  • 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.

Exclusion 16

  • 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
  • Indication of baseline delirium as determined by the Confusion Assessment Method (CAM).
  • Current use of lithium.
  • Inability to swallow CBD oil softgels.
  • Changes in dosage of anti-depressives within 4 weeks before randomization and during the study.
  • Changes in dosage of antipsychotics or benzodiazepines within 1 week prior to randomization and during the study.
  • Contraindications to CBD oil (history of hypersensitivity to any cannabinoid).
  • Frequent falling due to orthostatic hypotension.
  • Use of tricyclic antidepressants (TCA), fluoxetine, and/or carbamazepine. -Patients who reside in nursing homes.

Where

1 site, 1 recruiting

Eastern Virginia Medical School

Norfolk, Virginia, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.