Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Caring for a person with Alzheimer’s disease can have high physical, emotional, and financial costs. The demands of day-to-day care, changes in family roles, and decisions about placement in a care facility can be difficult. There are several evidence-based approaches and programs that can help, and researchers are continuing to look for new and better ways to support caregivers.
Becoming well-informed about the disease is one important strategy. Programs that teach families about the various stages of Alzheimer’s and about ways to deal with difficult behaviors and other caregiving challenges can help.
Good coping skills, a strong support network, and respite care are other ways to help caregivers handle the stress of caring for a loved one with Alzheimer’s disease. For example, staying physically active provides physical and emotional benefits.
Some caregivers have found that joining a support group is a critical lifeline. These support groups allow caregivers to find respite, express concerns, share experiences, get tips, and receive emotional comfort. Many organizations sponsor in-person and online support groups, including groups for people with early-stage Alzheimer’s and their families.
Alzheimer's disease is a progressive, degenerative disorder that attacks the brain's nerve cells, or neurons, resulting in loss of memory, thinking and language skills, and behavioral changes.
These neurons, which produce the brain chemical, or neurotransmitter, acetylcholine, break connections with other nerve cells and ultimately die. For example, short-term memory fails when Alzheimer's disease first destroys nerve cells in the hippocampus, and language skills and judgment decline when neurons die in the cerebral cortex.(source)
A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer’s Disease
This study will be conducted as a Phase 2, 12-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study designed to assess the safety and efficacy of pimavanserin at doses of 34 mg and 20 mg versus placebo in subjects with a diagnosis of probable AD according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) guidelines who have clinically significant agitation/aggression and who meet the following criteria:
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Do you or a loved one have..
What does it mean?
The SERENE clinical research study is looking for people with Alzheimer's disease who have agitated and aggressive behaviour.
How long is the study?
If you volunteer and qualify for this study, your loved one will receive study medication for up to 12-weeks. During the study they will be asked to make regular visits to the clinic. His or her health is very important to us, and will be monitored throughout the study.
How to participate?
Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.
You must be..
Age 50 or older
Diagonosed with Alzheimer's Disease
Showing agitated and aggressive behavior
Willingness and ability to comply with trial and follow-up procedures, give written consent
You can't be..
The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
Has a current major depressive disorder episode (within 3 months) according to the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria
Subject or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Qualified volunteers will recieve
No-cost study medication for agitation/agression in patients with Alzheimer's Disease