A prospective, randomized, double-blind, placebo-controlled, phase 2 efficacy and safety study of oral ELND005 for treatment of agitation and aggression in patients with moderate to severe Alzheimer's disease
Aimee L. Pierce, MD
UCI MIND at Gottschalk Medical Plaza and ICTS at Hewitt Hall
The HarmonyAD clinical study is being conducted to determine if an investigational drug given as a pill can safely reduce the symptoms of aggression and agitation in people with Alzheimer's disease.
Alzheimer's disease is frustrating. Sudden outbursts of anger, aggression or agitation are all part of the Alzheimer's disease process. Managing these symptoms can be difficult. But you are not alone. Doctors are working daily to find treatments.
To take part in this study, individuals must:
- Be at least 50 years old
- Have a diagnosis of Alzheimer's disease
- Experience at least moderate agitation and/or aggression
- Exhibit agitation and/or aggression at least once a week
- Have a study partner, informant or caregiver who is willing to participate in the study
The study will last approximately five and a half months (three months of active treatment with study drug or placebo). In total, participants will attend seven clinic visits, four telephone contact visits and be monitored throughout the study.
There may be no direct health benefits to you for participating in this study. You may get placebo, which means that you will not be taking active drug. If you are in the group the receives the study drug (ELND005, scyllo-inositol) and it proves to treat your condition better than placebo, you may benefit from participating in the study, but this cannot be guaranteed. The information collected from this study may increase knowledge regarding the treatment of Alzheimer's disease and help people in the future.
You may receive information from routine testing that is done in this study, but these tests may not have any impact on your health.
The investigational product and study-related procedures will be provided at no cost. For participants who travel some distance to the study site, a maximum of $30 will be provided for each visit required for the study.
Beatriz Yanez, RN