Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorEastern Virginia Medical School
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- THC-free CBD Oil
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Eastern Virginia Medical School
Lead sponsor
Old Dominion University
Collaborator
Ananda Hemp, Inc.
Collaborator
Source ClinicalTrials.gov