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Alzheimer DiseasePhase 2NCT04436081

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

A Phase 2 study testing THC-free CBD Oil in people with Alzheimer Disease and Dementia, run by Eastern Virginia Medical School at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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'… Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
THC-free CBD Oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
26 Feb 2021to Mar 2024
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Elkins, MS contact

757.446.5675

ELKINSDE@evms.edu

United States1 site, 1 recruiting

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510

    Hamid Okhravi, MD, 757-446-7040, okhravHR@evms.edu

    Hamid Okhravi, MD

    Recruiting

Other trials in United States

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.

Read the detailed description

Individuals with Alzheimer's and other forms of dementia often go through a period of significant behavioral and psychological symptoms of dementia (BPSD). It is estimated that up to 90% of persons with dementia (PWD) experience behavior problems at some point. BPSDs can be challenging for both unpaid family caregivers as well as paid caregivers. Family caregivers provide the bulk of care for PWD and number over 15 million. One of the most common types of BPSDs is agitation with a prevalence of up to 87%, based on a recent systematic review. Agitation can lead to impaired daily functioning, prolongation of hospitalization, reduced time to institutionalization, and is associated with higher mortality. Additionally, agitated behavior is associated with increased injury to both patients and caregivers. Based on the 2018 Alzheimer's disease drug development pipeline report almost 70% of clinical trials related to BPSD are dedicated to agitation behavior. Finding ways to address agitation is necessary to improve overall quality of life for PWD and their caregivers. Currently, there are no medications available specifically for the treatment of BPSDs. The use of benzodiazepines, antipsychotics and mood stabilizing agents are common, but the risks and side effects often outweigh any benefits.

Several small studies have investigated the use of cannabinoids in the treatment of pathology and symptomology of Alzheimer's disease (AD), as well as treatment of the agitation component of BPSD. A handful of these studies showed that the symptoms of BPSD were decreased with the use of cannabinoids. However, due to small sample sizes, study design, and short trial duration of these studies, the efficacy of these agents on BPSD cannot be confirmed. In addition, cannabinoids have demonstrated anti-oxidant and anti-inflammatory effects, and both processes have been indicated as major contributors to the neurologic effects of AD. Some evidence exists that agitation is related to this neuroinflammatory process. This study will examine the effects of cannabinoids on the behavioral and psychological symptoms of individuals with a dementia diagnosis.

Being tested
THC-free CBD Oil, Placebo
Keywords
Agitation, Aggression, Neuropsychiatric symptoms, CBD Oil, Cannabinoids, Caregiver burden, Sleep quality, Behavioral and Psychological Symptoms of Dementia, Neurocognitive disorders, Psychomotor agitation, Cannabidiols
Medical subject headings
Alzheimer Disease, Dementia, Psychomotor Agitation, Aggression, Caregiver Burden, Sleep Initiation and Maintenance Disorders, Behavior, Neurocognitive Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THC-free CBD OilDrug

    Hemp-based CBD oil Gelcaps

  • PlaceboDrug

    Placebo Gelcaps

Study groups in NCT04436081
Study groupRoleWhat they receive
Hemp-based CBD oil GelcapsActive comparatorThe intervention consists of 6 weeks oral administration of CBD oil Gelcaps, starting at a dosage of 15 mg twice per day with up titration to 45 mg twice per day. At any given dose, if participants develop side effects, the dosage will be reduced to the previous dose.
Receives: Drug: THC-free CBD Oil
Oral placebo GelcapsPlacebo comparatorParticipants in the control group will receive oral placebo Gelcaps that are identical in appearance to the CBD oil Gelcaps. Dosing will be identical to the intervention arm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in agitation and aggression.

    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.

    Measured: Every two weeks for 15 weeks during study enrollment.

  2. Change in caregiver burden.

    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.

    Measured: Three times during the 15 weeks of study enrollment.

  3. Change in the participant's quality of life.

    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.

    Measured: Three times during the 15 weeks of study enrollment.

  4. Change in caregiver's quality of life.

    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.

    Measured: Three times during the 15 weeks of study enrollment.

Secondary outcomes (3)

  1. Assessment of change in neuropsychiatric symptoms.

    Assessment of change in neuropsychiatric symptoms for the participant will be measured by the Neuropsychiatric Inventory (NPI), a validated questionnaire that assesses dementia-related behavioral symptoms. The NPI examines 12 sub-domains of behavioral functioning. Each sub-domain is rated on the frequency of the symptoms using a 4-point scale with 1 "Occasionally" and 4 "Very frequently", the severity of the symptoms using a 3-point scale with 1 "Mild" and 3 "Marked", and the distress the symptom causes them on a 5-point scale with 1 "Not at all" and 5 "Very severely or extremely".

    Measured: Three times during the 15 weeks of study enrollment.

  2. Assessment of change in cognitive skills.

    Assessment of change in cognitive skills for the participant will be measured by the Mini Mental State Exam (MMSE), a validated 30-item questionnaire used to measure cognitive impairment among the elderly. A 30-item, clinician-administered assessment of orientation, attention, calculation, learning and memory, language, and visuospatial skills. Each correct response is summed to produce a total score out of 30 possible points.

    Measured: Three times during the 15 weeks of study enrollment.

  3. The effect of CBD oil on sleep quantity measured by Fitbit

    The effect of CBD oil on sleep quality will be measured for the participant and caregiver using the actigraphy function of fit bit. These measures include the amount of total sleep, amount of rapid eye movement (REM) sleep and the amount of deep and light sleep.

    Measured: Measured on a daily basis during the 15 weeks of study enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2020
  2. Study start26 Feb 2021
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04436081
Sponsor's protocol ID
RI-03368
Status last verified
Feb 2023
First submitted
12 Jun 2020
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. Behavioral and psychological symptoms of dementia. Front Neurol. 2012 May 7;3:73. doi: 10.3389/fneur.2012.00073. eCollection 2012.

    PubMed 22586419

  • van der Linde RM, Dening T, Stephan BC, Prina AM, Evans E, Brayne C. Longitudinal course of behavioural and psychological symptoms of dementia: systematic review. Br J Psychiatry. 2016 Nov;209(5):366-377. doi: 10.1192/bjp.bp.114.148403. Epub 2016 Aug 4.

    PubMed 27491532

  • Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369.

    PubMed 25731881

  • Okura T, Langa KM. Caregiver burden and neuropsychiatric symptoms in older adults with cognitive impairment: the Aging, Demographics, and Memory Study (ADAMS). Alzheimer Dis Assoc Disord. 2011 Apr-Jun;25(2):116-21. doi: 10.1097/WAD.0b013e318203f208.

    PubMed 21192239

  • Yaffe K, Fox P, Newcomer R, Sands L, Lindquist K, Dane K, Covinsky KE. Patient and caregiver characteristics and nursing home placement in patients with dementia. JAMA. 2002 Apr 24;287(16):2090-7. doi: 10.1001/jama.287.16.2090.

    PubMed 11966383

  • Khan SS, Ye B, Taati B, Mihailidis A. Detecting agitation and aggression in people with dementia using sensors-A systematic review. Alzheimers Dement. 2018 Jun;14(6):824-832. doi: 10.1016/j.jalz.2018.02.004. Epub 2018 Mar 20.

    PubMed 29571749

  • Cummings J, Lee G, Ritter A, Zhong K. Alzheimer's disease drug development pipeline: 2018. Alzheimers Dement (N Y). 2018 May 3;4:195-214. doi: 10.1016/j.trci.2018.03.009. eCollection 2018.

    PubMed 29955663

  • Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

    PubMed 7991117

  • Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.

    PubMed 2715584

  • Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

    PubMed 7203086

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Smith SC, Lamping DL, Banerjee S, Harwood RH, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Development of a new measure of health-related quality of life for people with dementia: DEMQOL. Psychol Med. 2007 May;37(5):737-46. doi: 10.1017/S0033291706009469. Epub 2006 Dec 19.

    PubMed 17176501

  • Smith SC, Lamping DL, Banerjee S, Harwood R, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Measurement of health-related quality of life for people with dementia: development of a new instrument (DEMQOL) and an evaluation of current methodology. Health Technol Assess. 2005 Mar;9(10):1-93, iii-iv. doi: 10.3310/hta9100.

    PubMed 15774233

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing THC-free CBD Oil in people with Alzheimer Disease and Dementia, run by Eastern Virginia Medical School at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Elkins, MS (757.446.5675, ELKINSDE@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in agitation and aggression. (time frame: Every two weeks for 15 weeks during study enrollment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04436081, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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