Frequently Asked Questions

About the Study

Is a diagnosis of Alzheimer’s disease or dementia required to participate?

Yes. A diagnosis of Alzheimer’s disease or another type of dementia is required and can be confirmed during the screening process. We encourage you to contact the potential participant’s nearest study site to get more information on this process and other eligibility requirements.

What is a study partner and what is their role in the study?

A study partner is someone who has at least 5 hours of contact with the study participant per week and is able to participate in all in-person and telephone visits. The study partner will be asked to provide information about the participant’s behavior and health.

What does it mean to be “hospice care eligible?”

A person becomes “hospice care eligible” when a medical provider determines the person is approaching or has reached their final stages of life. For more information on the eligibility requirements for hospice care or to find out if your loved one is eligible, please contact your loved one’s medical provider or the nearest study site.

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What do agitation symptoms in someone with Alzheimer’s disease or dementia look like?

Agitation symptoms can be different for everyone. We recommend contacting your loved one’s medical provider or the nearest study site to help confirm if they have agitation symptoms and are eligible to participate in the LiBBY Study.

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Below are a couple of examples of people suffering from agitation in their final stages of life:

Example 1: An 85-year-old woman has been suffering from dementia for approximately 8 years. Lately she has been having difficulties swallowing. As a result, she developed aspiration pneumonia and eligibility for hospice care was confirmed. With the aspiration pneumonia, her consciousness became increasingly cloudy, and she developed physically and verbally aggressive behaviors, including shouting incomprehensible words. She also tried to get out of bed by herself and fell and began to scratch her own skin.

Example 2: A 60-year-old man suffered from a stroke 10 years ago and another large stroke 4 weeks ago. Following the second stroke, the patient developed severe cognitive impairment and, due to his motor impairment causing a lack of mobility, he also developed several pressure ulcers. Since his second stroke, he developed severe motor aggression including punching and hitting anyone who approached him. He would also rip his bed sheets and vocalize strange noises. He was treated with morphine, valium, and Haldol with no response. However, he developed severe constipation, increased confusion, and itching due to the prescribed medications, which increased his agitation.

What is a Legally Authorized Representative (LAR)?

A Legally Authorized Representative (LAR) is someone that has been given legal permission to make medical decisions on behalf of the person receiving medical care. We encourage you to contact the potential participant’s nearest study location for more information.

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What does it mean if a study is placebo-controlled and double-blinded?

A placebo-controlled study means that once eligibility is confirmed, the individual study participant will be designated at random to receive the treatment under investigation, or a placebo. A placebo is designed to look like the treatment under investigation but does not have any active ingredients. In the LiBBY Study, the treatment under investigation is a THC/CBD oral combination digestible oil.

Half the participants will be selected at random to receive the treatment under investigation and the other half will be selected at random to receive the placebo. The selection process is random, and like the flip of a coin, the chances of being selected to receive the treatment under investigation or the placebo are equal (half and half).

Double-blinded means that throughout the study, researchers, participants, and their caregivers will not know if individual study participants are taking the investigational treatment (THC/CBD oral combination) or the placebo. In a double-blinded study, specific researchers are authorized to be “unblinded,” which means, when necessary for safety reasons, they will be able to know if a study participant is taking the investigational treatment. Double-blinding helps to ensure accurate study results, and unblinding helps to ensure study participant safety.

Why is the LiBBY Study, and other studies, placebo-controlled and double-blinded?

Studies, like LiBBY, are placebo-controlled and double-blinded to help researchers discover if the investigational medication or treatment being studied is effective. By using a placebo-controlled method, researchers can compare the study medication to no medication (placebo) in treating an illness or symptom. By including the double-blinded method, information shared by study participants and staff remains honest and accurate.

Does participating in the study mean that other medications/therapies will be removed?

No. The medications a potential study participant is taking will remain under the management of their prescribing medical provider. For additional guidance, we encourage you to consult with the potential participant’s medical provider or their nearest study site.

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How can I help my loved one participate in this study?

To help your loved one participate in this study, contact their closest study location to find out how to get started.

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Who is paying for this study?

The LiBBY Study is funded by the National Institute on Aging (NIA) of the National Institutes of Health (NIH) and led by researchers at the Medical University of South Carolina, Georgetown University, and the University of Southern California’s (USC) Alzheimer’s Therapeutic Research Institute (ATRI).

Are there guidelines to protect against COVID-19?

Guidelines and protections against COVID-19 may vary by site. Contact the nearest location for more information.

About THC and CBD

What do people mean when they use the terms marijuana, Cannabis, THC, and CBD?

The words marijuana and Cannabis are often used in place of one another. The term Cannabis actually covers a larger plant family (group) with different species (types). Two of those plant species are marijuana and hemp.

Cannabis covers a group of plants that can have over 100 active ingredients called cannabinoids. Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD), are just two of those cannabinoids that can be found in Cannabis plants. All Cannabis contains varying amounts of cannabinoids.

  • Marijuana – Cannabis strains (varieties) that have high levels of THC (greater than 0.3% THC by weight) are typically referred to as marijuana.
  • Hemp – Cannabis varieties that typically have lower levels of THC (below 0.3% THC by weight) are commonly referred to as hemp.

THC is found in marijuana plants, has some therapeutic effects, and is the ingredient that produces the psychoactive effect, or “high.” CBD can be found in hemp and marijuana, has some therapeutic effects, and is a chemical that is non-psychoactive, or does not give you a “high.”

Why test THC and CBD for treatment of agitation in patients with Alzheimer’s disease and dementia?

Agitation is a common unwanted symptom in patients with dementia and a significant challenge for both patients and caregivers. There is no U.S. Food and Drug Administration (FDA) approved treatment for agitation in Alzheimer’s disease or dementia. Medications typically prescribed to manage agitation in dementia patients come with several risks including falls, confusion, and pneumonia.

Preliminary research suggests that the use of a combination of both THC and CBD may allow for the effective management of agitation in dementia patients with fewer risks than commonly prescribed medications.

Why test THC and CBD to treat agitation at end-of-life (EoL) stages in dementia?

Hospice care is a form of comfort care that focuses on the management of pain in addition to the physical, emotional, and spiritual well-being of the patient. At the end-of-life, hospice care can be helpful in maintaining the highest quality of life possible, particularly as the patient becomes more fragile and vulnerable to the negative effects of many medications.

Evidence suggests that the use of THC and CBD in terminally ill patients may offer benefits consistent with hospice care. Possible benefits include reductions in agitation and improvements on caregiver burden caused by commonly prescribed treatments for people at EoL stages.

The LiBBY Study is testing THC and CBD as a treatment for agitation in hospice eligible patients with Alzheimer’s disease or dementia. Study results will provide a better understanding of the potential benefits of THC and CBD treatment for multiple aspects of end-of-life care.

Are THC and CBD safe? What are the medicinal uses of THC and CBD? Are there side effects?

THC and CBD, at the doses used in this study, are believed to have a low risk profile. In 2018, the U.S. Food and Drug Administration (FDA) approved the use of CBD developed from Cannabis for the treatment of some forms of epilepsy. Three manufactured forms of THC have been approved by the FDA for the management of nausea and appetite: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone).

The commonly reported side effects from THC and CBD use include drowsiness, fatigue, dry mouth, and changes in appetite.

The dose of THC and CBD that is being tested in this study has been carefully selected to minimize potential for adverse reactions. Study participants will be monitored for unwanted side effects.

If concerns for participant safety arise, the study medication will be discontinued and can be discontinued at any time upon request of the participant or their caregiver.

If THC or CBD use is not legal where a potential study participant resides, can they still participate in the LiBBY Study?

Yes. Even though THC or CBD use may not be legal for medical or recreational use where a potential study participant lives, they may be eligible to participate in the LiBBY Study. State laws relating to the medical or recreational use of THC or CBD do not apply to use of THC or CBD as part of a research study.

For more information – Contact Your Nearest Study Site