This study tests a medication called dronabinol in people with Alzheimer's disease. First, participants go through up to 4 weeks of screening. Then, over 2 weeks, the dose of the study drug is slowly increased. For the next 10 weeks, participants stay on either dronabinol or a placebo.
After finishing this part of the study, participants can join a 6-month extension where everyone receives dronabinol. Those already on the drug stay on their same dose, while those who were on placebo gradually increase their dose over 2 weeks.
All participants take dronabinol for the rest of the extension, then complete a final safety check 4 weeks after stopping the medication. Usual medical treatments are continued throughout the study.
1. Participant or legal representative is willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and is willing and able to return for all study visits and comply with all protocol requirements and procedures.
2. Adult males and females, 50 to 90 years of age (inclusive) at screening.
3. Participants must have a diagnosis of dementia due to AD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and a diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
4. Presence of Agit-AD as defined by the provisional criteria from the International Psychogeriatric Association (IPA). The definition requires the presence of cognitive impairment, evidence of emotional distress, one of three observable types of behaviour (excessive motor activity, verbal aggression, physical aggression), requires that the behaviour cause excess disability, and notes that the behaviours cannot be solely attributable to another disorder such as psychiatric illness, medical illness, or effects of substance use.
1. Known hypersensitivity to the study drug or any of the study drug ingredients.
2. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
3. History or presence of clinically significant, unstable (not well controlled on medications) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
4. History of recurrent falls (≥2 falls within 6 months prior to Screening) resulting in injury or associated with acute illness, loss of consciousness, or abnormal vital signs, history of fall with fracture within 12 months of Screening.
Benuvia Therapeutics Inc.
Lead sponsor
Mandara
Collaborator