RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (1)

VA