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Dronabinol for Agitation in Alzheimer's Disease (THC-AD Trial)

Phase 2

Recruiting

Led By Paul Rosenberg

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of Agit-AD as defined by the provisional criteria from the International Psychogeriatric Association (IPA)

Clinically significant severity of agitation defined by NPI-C Agitation or NPI-C Aggression > 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-weeks

Awards & highlights

THC-AD Trial Summary

This trial is testing whether or not a drug commonly used to treat nausea caused by chemotherapy can also help reduce symptoms of Alzheimer's disease, specifically agitation.

Who is the study for?

This trial is for adults aged 60-95 with Alzheimer's Disease who experience significant agitation. Participants must be inpatients or able to visit certain hospitals, and fluent in English/Spanish. Those with serious illnesses, seizure disorders, delirium, or unable to swallow pills cannot join.Check my eligibility

What is being tested?

The study tests Dronabinol (Marinol®), a potential treatment for agitation in Alzheimer's patients, against a placebo. It aims to determine if Dronabinol can safely reduce agitation symptoms and improve quality of life.See study design

What are the potential side effects?

Dronabinol may cause dizziness, drowsiness, dry mouth, feeling high or having an altered mental state. Since it's being tested on elderly patients with AD who might be sensitive to drugs' effects, monitoring for any adverse reactions is crucial.

THC-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with agitation related to Alzheimer's disease.

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I experience severe agitation or aggression.

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I am between 60 and 95 years old.

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I can be at McLean, Johns Hopkins, or Miami Jewish Health for 3 weeks.

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I have been diagnosed with Alzheimer's disease.

THC-AD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Symptoms of agitation as measured by the Neuropsychiatric Inventory, Clinician Version

Symptoms of agitation as measured by the Pittsburgh Agitation Scale

Secondary outcome measures

Adverse events in Dronabinol treatment as compared to placebo

THC-AD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DronabinolExperimental Treatment1 Intervention

Study medication will be administered twice daily. Capsules of dronabinol will contain 2.5 mg per dose (5mg daily) during Week 1, then increase to 5 mg per dose (10mg daily) for Weeks 2 and 3.

Group II: PlaceboPlacebo Group1 Intervention

Placebo medication will be administered twice daily.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,853 Total Patients Enrolled

Tufts Medical CenterOTHER

253 Previous Clinical Trials

253,238 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,259 Previous Clinical Trials

14,820,493 Total Patients Enrolled

Media Library

Dronabinol (Marinol®) Clinical Trial Eligibility Overview. Trial Name: NCT02792257 — Phase 2

Alzheimer's Disease Research Study Groups: Dronabinol, Placebo

Alzheimer's Disease Clinical Trial 2023: Dronabinol (Marinol®) Highlights & Side Effects. Trial Name: NCT02792257 — Phase 2

Dronabinol (Marinol®) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02792257 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the benefits of this treatment extend to patients in their golden years?

"This study's age limit is 60 years old minimum and 95 years old maximum, as specified in the inclusion criteria."

Answered by AI

How many people are being given the opportunity to participate in this experiment?

"Yes, the information on clinicaltrials.gov points out that this study is presently searching for patients. The clinical trial was originally posted on 3/1/2017 and was last edited on 8/9/2022. The clinical trial is admitting 160 participants at 4 sites."

Answered by AI

For what reasons is Dronabinol (Marinol®) most commonly prescribed?

"Dronabinol is a medication used to manage weight loss and stimulate appetite. It's often prescribed when patients don't respond well to other forms of therapy."

Answered by AI

Could you walk me through the other research that's been done on Dronabinol (Marinol®)?

"Dronabinol (Marinol®) was first studied in the year 2014 at VA Connecticut Healthcare System. So far, there have been a total of 18356 completed studies. 44 clinical trials are still recruiting patients as of now, with many of them based in Salem, Florida."

Answered by AI

Are patients at risk when taking Dronabinol (Marinol®)?

"Dronabinol (Marinol®) has been given a score of 2 for safety. Although there is some data suggesting that it is safe, none of the available evidence supports its efficacy."

Answered by AI

Is this clinical trial being conducted at more than one facility in our state?

"There are 4 primary sites conducting this clinical trial, with additional locations in Salem, Miami and Baltimore. To limit participant burden, it is recommended that you select the nearest centre to your location."

Answered by AI

Are recruitment efforts for this research project still underway?

"Yes, this information is correct. The clinical trial was posted on 3/1/2017 and was last updated on 8/9/2022 according to the website."

Answered by AI

Could I join this research project?

"This study is recruiting 160 participants, within the ages of 60 and 95 who currently have akathisia. It is important that patients also meet the following criteria: Must be admitted to clinical sites associated with McLean Hospital, Johns Hopkins University, and Miami Jewish Health Services as an inpatient/long term care resident during the study duration (3 weeks) OR be able to travel to these locations to enroll as an outpatient., Clinically significant severity of agitation defined by NPI-C Agitation or NPI-C Aggression > 4., Presence of Agit-AD as defined by the provisional criteria from the International Psych"

Answered by AI