What side effects are associated with this type of intervention?

Cannabinoid-based treatments like Dronabinol (Marinol®), which are used to manage symptoms such as agitation in Alzheimer's Disease, commonly cause side effects including dizziness, sedation, confusion, and dissociation. These treatments can also lead to gastrointestinal issues like nausea and diarrhea, as well as disturbed sleep patterns. Additionally, patients may experience a 'high' sensation, which can be uncomfortable and disorienting. It is important to monitor these side effects closely and discuss them with a healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on symptom management and slowing disease progression. These include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and an NMDA receptor antagonist (memantine). While these drugs do not work in the same way as Dronabinol, which is a synthetic THC that binds to cannabinoid receptors to influence neurotransmitter release and reduce agitation, they aim to manage cognitive symptoms and improve quality of life. There are no FDA-approved treatments specifically targeting agitation in Alzheimer's Disease using cannabinoid-based therapies like Dronabinol.

What other types of research exist?

Promising novel alternatives to Dronabinol for treating agitation in Alzheimer's Disease patients include: 1) Cannabidiol (CBD), which has shown potential in reducing neuropsychiatric symptoms with a favorable safety profile. 2) Lemborexant, a dual orexin receptor antagonist, which has been effective in managing insomnia and may help with agitation related to sleep disturbances. 3) Brexpiprazole, an atypical antipsychotic with a better side effect profile, has shown promise in managing agitation and other behavioral symptoms in dementia.

← Back to Search

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

Phase 2

Waitlist Available

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

Must not have

Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes

Seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing Dronabinol, a synthetic form of THC, to see if it can help reduce severe agitation in Alzheimer's patients. The drug works by targeting brain receptors to reduce anxiety, depression, and inflammation. This could provide a new treatment option for a challenging symptom of Alzheimer's disease. Dronabinol has been previously reported as a potential treatment for neuropsychiatric symptoms in dementia, including agitation and aggressive behavior.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I experience severe agitation or aggression.

Select...

I am between 60 and 95 years old.

Select...

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

Select...

I have been diagnosed with Alzheimer's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious illnesses that could affect the study's safety assessment.

Select...

I have a seizure disorder.

Select...

I have been diagnosed with delirium.

Select...

I am currently taking lithium.

Select...

I cannot swallow pills.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Symptoms of agitation as measured by the Pittsburgh Agitation Scale

Secondary study objectives

Adverse events in Dronabinol treatment as compared to placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dronabinol

FDA approved

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) often target neurotransmitter systems to alleviate symptoms. Dronabinol, a synthetic THC, binds to cannabinoid receptors to influence neurotransmitter release, reducing agitation—a significant neuropsychiatric symptom in AD. This is crucial as agitation is a major source of distress for patients and caregivers. Other treatments, such as cholinesterase inhibitors (e.g., donepezil), increase acetylcholine levels to enhance cognitive function, while NMDA receptor antagonists (e.g., memantine) regulate glutamate activity to prevent excitotoxicity. These mechanisms are vital for improving both cognitive and behavioral symptoms, thereby enhancing the quality of life for AD patients and easing caregiver burden.