Trial · NCT02792257

Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease

NCT02792257, Phase 2, Completed, Johns Hopkins University; results first posted 2025-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease. Trials, record NCT02792257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02792257

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease
NCT number: NCT02792257
Status: Completed
Phases: Phase 2
Enrollment: 84 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Alzheimer's Disease
Interventions: Dronabinol (Marinol®), Placebo
First posted: 2016-06-07
Last updated: 2025-05-09
Results first posted: 2025-05-09

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Up to 3 weeks	The Pittsburgh Agitation Scale (PAS) is a tool used to assess the severity of agitation in patients, particularly with dementia. The minimum score is 0 and the maximum score is 16. A higher number means a worse outcome, meaning more agitation.
Primary	Symptoms of Agitation as Measured by the Neuropsychiatric Inventory, Clinician Version	Up to 3 weeks	The Neuropsychiatric Inventory Clinician Version (NPI-C) is an assessment tool used to evaluate neuropsychiatric symptoms in patients, particularly those with dementia. The minimum score is 0 and the max is 426. Higher scores indicate worse outcomes, meaning more agitation.
Secondary	Number of Participants With Adverse Events in Dronabinol Treatment as Compared to Placebo	Up to 3 weeks	All Adverse Events (AE) s occurring after randomization and during the 3-week treatment period, regardless of adherence to study treatment, will be recorded at all contacts.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Up to 3 weeks	score on a scale	MEAN
PRIMARY	Symptoms of Agitation as Measured by the Neuropsychiatric Inventory, Clinician Version	Up to 3 weeks	score on a scale	MEAN
SECONDARY	Number of Participants With Adverse Events in Dronabinol Treatment as Compared to Placebo	Up to 3 weeks	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Dronabinol	Week 0	7.14	Standard Deviation 4.12	score on a scale
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Placebo	Week 0	5.55	Standard Deviation 4.18	score on a scale
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Dronabinol	Week 1	5.69	Standard Deviation 4.36	score on a scale
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Placebo	Week 1	4.97	Standard Deviation 3.81	score on a scale
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Dronabinol	Week 2	5.73	Standard Deviation 4.67	score on a scale
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Placebo	Week 2	5.22	Standard Deviation 4.24	score on a scale
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Dronabinol	Week 3	4	Standard Deviation 3.52	score on a scale
Symptoms of Agitation as Measured by the Pittsburgh Agitation Scale	Placebo	Week 3	5.13	Standard Deviation 4.44	score on a scale
Symptoms of Agitation as Measured by the Neuropsychiatric Inventory, Clinician Version	Dronabinol	Week 0	76.68	Standard Deviation 34.19	score on a scale
Symptoms of Agitation as Measured by the Neuropsychiatric Inventory, Clinician Version	Placebo	Week 0	76.37	Standard Deviation 48.62	score on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dronabinol	37
Overall Study	STARTED	Placebo	38
Overall Study	COMPLETED	Dronabinol	32
Overall Study	COMPLETED	Placebo	31
Overall Study	NOT COMPLETED	Dronabinol	5
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events82

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Delirium	Psychiatric disorders	Dronabinol	1	37	1
other	Delirium	Psychiatric disorders	Placebo	2	38	3
other	Fall	General disorders	Dronabinol	3	37	4
other	Fall	General disorders	Placebo	5	38	6
other	Seizure	Nervous system disorders	Dronabinol	0	37	0
other	Seizure	Nervous system disorders	Placebo	1	38	1
other	Anemia	Blood and lymphatic system disorders	Dronabinol	0	37	0
other	Anemia	Blood and lymphatic system disorders	Placebo	1	38	1
other	Leukopenia	Blood and lymphatic system disorders	Dronabinol	1	37	1
other	Leukopenia	Blood and lymphatic system disorders	Placebo	0	38	0

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dronabinol	0	37
Total, all-cause mortality	Placebo	0	38
Total, other adverse events	Dronabinol	21	37
Total, other adverse events	Placebo	20	38
Total, serious adverse events	Dronabinol	2	37
Total, serious adverse events	Placebo	0	38

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33660625	DERIVED	PubMed
34532852	DERIVED	PubMed
34629131	DERIVED	PubMed
41350162	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AG050515	Pilot trial of dronabinol adjunctive treatment of agitation in Alzheimer's disease (AD)	ROSENBERG, PAUL B; FORESTER, BRENT PETER	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE ON AGING	2016 to 2021

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dronabinol vs Placebo: deaths from any cause	Trial comparisons
Dronabinol vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02792257

GET https://conductscience.org/api/trials/v1/NCT02792257/results?page=2

API reference For AI assistants