RECRUITING

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

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Conditions

Alzheimer DiseaseDementiaMajor Neurocognitive Disorder With Aggressive BehaviorAgitationAggressionNeuropsychiatric symptomsCBD OilCannabinoidsCaregiver burdenSleep qualityBehavioral and Psychological Symptoms of DementiaNeurocognitive disordersPsychomotor agitationCannabidiols

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-26
Study Completion:2024-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04436081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males/females over 50 years old.
  2. * Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.
  3. * A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive.
  4. * Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation/aggression subscore \> 3.
  5. * Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent.
  6. * 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.
  7. * Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them.
  1. * Diagnosis of non-AD or non-mixed dementias.
  2. * Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4).
  3. * NPI-agitation-aggression score \< 3.
  4. * 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.
  5. * Presence or history of other serious psychiatric disorders or neurological conditions (e.g. psychotic disorders, bipolar disorder or schizophrenia).
  6. * Current abuse of/dependence on marijuana, current drug abuse, current alcohol abuse.
  7. * Having seizure disorders.
  8. * Pregnant or breastfeeding
  9. * Indication of baseline delirium as determined by the Confusion Assessment Method (CAM).
  10. * Current use of lithium.
  11. * Inability to swallow CBD oil softgels.
  12. * Changes in dosage of anti-depressives within 4 weeks before randomization and during the study.
  13. * Changes in dosage of antipsychotics or benzodiazepines within 1 week prior to randomization and during the study.
  14. * Contraindications to CBD oil (history of hypersensitivity to any cannabinoid).
  15. * Frequent falling due to orthostatic hypotension.
  16. * Use of tricyclic antidepressants (TCA), fluoxetine, and/or carbamazepine. -Patients who reside in nursing homes.

Contacts and Locations

Study Contact

David Elkins, MS
CONTACT
757.446.5675
ELKINSDE@evms.edu

Principal Investigator

Hamid Okhravi, MD
PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School

Study Locations (Sites)

Eastern Virginia Medical School
Norfolk, Virginia, 23510
United States

Collaborators and Investigators

Sponsor: Eastern Virginia Medical School

  • Hamid Okhravi, MD, PRINCIPAL_INVESTIGATOR, Eastern Virginia Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-26
Study Completion Date2024-03

Study Record Updates

Study Start Date2021-02-26
Study Completion Date2024-03

Terms related to this study

Keywords Provided by Researchers

  • Agitation
  • Aggression
  • Neuropsychiatric symptoms
  • CBD Oil
  • Cannabinoids
  • Caregiver burden
  • Sleep quality
  • Behavioral and Psychological Symptoms of Dementia
  • Neurocognitive disorders
  • Psychomotor agitation
  • Cannabidiols

Additional Relevant MeSH Terms

  • Alzheimer Disease
  • Dementia
  • Major Neurocognitive Disorder With Aggressive Behavior