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Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia

Study acronym: CBD
StatusActive, Not Recruiting
PhaseEarly Phase 1
Started2021-01-11
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-01-16→2026-12
Completion date2026-01-16→2026-12
Study sitesdetails revised at 1 of 1 site
2025-05-05
Study Status, Oversight, Conditions, Contacts/Locations v11
Primary completion date2025-07-16→2026-01-16
Completion date2025-07-16→2026-01-16
2024-08-01
Study Status, Eligibility v10
Primary completion date2024-09-15→2025-07-16
Completion date2024-09-15→2025-07-16
Eligibility criteriarevised
[...] s and their study partner must be fluent in English Must be 6055-90 years old (inclusive) Exclusion Criteria: Serious or uns [...]
2024-03-07
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v9
Eligibility criteria+8 characters
Inclusion Criteria: Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI MMSE score of 15-2430 (inclusive) Clinically significant degree of anxiety, as de [...]
Study title+29 characters
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
2023-10-17
Study Status, Eligibility, Contacts/Locations v8
Primary completion date2023-09-15→2024-09-15
Completion date2023-09-15→2024-09-15
Study sitescontacts updated at 1 of 1 site
Show 7 earlier versions
2023-01-17
Study Status, Contacts/Locations v7
Primary completion date2023-01-11→2023-09-15
Completion date2023-01-11→2023-09-15
2022-04-04
Study Status v6
Primary completion date2022-01-11→2023-01-11
Completion date2022-01-11→2023-01-11
2021-03-08
Study Status, Sponsor/Collaborators v5
Re-verified, no change to tracked fields
2021-03-04
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2021-02-26
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2021-11-01→2022-01-11
Completion date2021-11-01→2022-01-11
Start dateestimated 2020-03-01→confirmed 2021-01-11
Eligibility criteria-77 characters
[...] , as defined by a Clinical Impression total column score of >≥4 on the Anxiety domain of the NPI-C A health care proxy ava [...] bipolar disorder, schizophrenia, schizoaffective disorder, or any personality disorder, as determined by the Mini International Neuropsychiatric Interview (MINI) Current episode of major depression, as determined by the M [...]
Secondary endpoints3 to 5 entries
SafetyTotal definedscore byon absencethe Generalized Anxiety Disorder 7 scale Number of serious adverse events SafetyWeek as8 definedMMSE bytotal lackscore compared to baseline MMSE total score Score on the confusion assessment method Number and severity of treatmentside emergenteffects cognitive impairment as measured by the Mini Mental Status Exam (MMSE) Safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)reported
Primary endpoints2 to 1 entries
AnxietyTotal Domainof clinician impression column on theanxiety Neuropsychiatricdomain Inventory-Clinician scale Total score onof the Generalized Anxiety Disorder 7 scaleNPI-C
2020-02-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2019-11-01→2020-03-01
Study sites0→1
2019-09-25
Study Identification, Study Status v1
Study title-17 characters
Open-LabelCannabidiol Trial of Medical MarijuanaSolution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia
2019-08-29
Original filing
Mclean Hospital
53 trials monitored
See 1 trial at risk
Anxiety
2,229 trials monitored
See 91 trials at risk
Alzheimer's Disease
1,140 trials monitored
See 62 trials at risk
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
Trial Details
NCT Number NCT04075435
Lead Sponsor Mclean Hospital
Collaborators: Spier Family Foundation
Conditions Alzheimer Disease, Anxiety, Agitation,Psychomotor, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Enrollment 12 participants
Start Date 2021-01-11
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-30