Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
NCT ID: NCT04436081
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2021-02-26
2024-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Hemp-based CBD oil Gelcaps
The 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.
THC-free CBD Oil
Hemp-based CBD oil Gelcaps
Oral placebo Gelcaps
Participants 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.
Placebo
Placebo Gelcaps
Interventions
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THC-free CBD Oil
Hemp-based CBD oil Gelcaps
Placebo
Placebo Gelcaps
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
90 Years
ALL
No
Sponsors
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Old Dominion University
OTHER
Ananda Hemp, Inc.
UNKNOWN
Eastern Virginia Medical School
OTHER
Responsible Party
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Hamid Okhravi, M.D.
Associate Professor of Geriatrics and Director of Memory Clinic
Principal Investigators
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Hamid Okhravi, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School
Locations
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Eastern Virginia Medical School
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RI-03368
Identifier Type: -
Identifier Source: org_study_id
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