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NCT04436081 · ClinicalTrials.gov registry record · Phase 2
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
A Phase 2 study, sponsored by Eastern Virginia Medical School.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04436081: Recruiting Phase 2 study, sponsored by Eastern Virginia Medical School.
NCT04436081 is a Phase 2 study that is actively recruiting participants, run by Eastern Virginia Medical School. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04436081, a Phase 2 study, is actively recruiting participants, sponsored by Eastern Virginia Medical School.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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' quality of life.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG THC-free CBD Oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-02-26 |
| Est. Completion | 2024-03 |
| Phase | Phase 2 |
What NCT04436081 shows while recruiting
NCT04436081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04436081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04436081 about?
NCT04436081 is a clinical study titled "Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease". 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 p...
What is the current status of trial NCT04436081?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2021-02-26. Estimated completion is 2024-03.
What interventions are being tested in trial NCT04436081?
The interventions under investigation include: Placebo (DRUG), THC-free CBD Oil (DRUG).
Who is sponsoring clinical trial NCT04436081?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04436081's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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