NCT04436081 · Eastern Virginia Medical School
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
What this study is about
This is a randomly assigned, double-blinded, compared against an inactive treatment, crossover trial that aims to 1) determine the effectiveness 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.
View original scientific 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.
Interventions
DRUG
THC-free CBD Oil
Hemp-based CBD oil Gelcaps
DRUG
Placebo
Placebo Gelcaps
Primary outcome measures
Change in agitation and aggression.
Time frame: Every two weeks for 15 weeks during study enrollment.
Change in agitation and aggression will be measured by the Cohen-Mansfield Agitation Inventory (CMAI), a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 "Never" to 7 "Several times per hour". Higher scores indicate greater agitation.
Change in caregiver burden.
Time frame: Three times during the 15 weeks of study enrollment.
Change in caregiver burden will be measured by the Zarit Burden Interview (ZBI), a validated 22-item questionnaire to assess caregiver burden. Each item is rated on a 5-point Likert scale that ranges from 0 "Never" to 4 "Nearly always," with the sum of scores ranging between 0-88. Higher scores indicate greater burden.
Change in the participant's quality of life.
Time frame: Three times during the 15 weeks of study enrollment.
Change in the participant's quality of life will be measured by the Quality-of-life assessment in dementia (DEMQOL-proxy), a validated 32-item questionnaire to assess the health related quality of life of people with dementia. Each item is rated on a 4-point scale ranging from 1 "A lot" to 4 "Not at all". Higher scores indicate a healthier quality of life.
Change in caregiver's quality of life.
Time frame: Three times during the 15 weeks of study enrollment.
Change in the caregiver's quality of life will be measured by the Measurement of quality of life in family carers of people with dementia (C-DEMQOL), a validated 30-item questionnaire to assess the quality of life for carers of someone with dementia. Each item is rated on a 5-point scale ranging from 1 "Completely" to 5 "Not at all." Higher scores indicate a healthier quality of life.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Norfolk, Virginia
Collaborators
Old Dominion University, Ananda Hemp, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 16, 2023 · Source of record for eligibility and locations