Santa Ana, CA -- (SBWIRE) -- 02/26/2020 -- A leading clinical research facility, CITrials clinical work has helped Merck to get FDA approval for a new use of its insomnia drug Belsomra, treating sleep disruption in people with mild-to-moderate Alzheimer's disease. The approval for this label is based on clinical trials done in CITrials. Belsomra's activity in Alzheimer's was demonstrated in a 285-subject, four-week sleep study, published in Alzheimer's & Dementia, which found significant improvements compared to placebo in total sleep time (TST) and wake after sleep onset (WASO) measures.
Unlike some other insomnia drugs available on the market, Belsomra doesn't seem to lead to a significant increase in confusion and falls in people who are cognitively impaired. The rate of falls in the study at 2% versus 0% in the placebo group, while somnolence the following day was reported in 4.2% and 1.4% of subjects, respectively.
Alzheimer's disease causes problems with memory, thinking, and behavior. Symptoms usually develop slowly and get worse over time as dementia progresses in severity. Alzheimer's disease is the most common cause of dementia. People with Alzheimer's & dementia typically experience poor sleep and disruption of circadian rhythms that lead to night-time activity and daytime sleepiness.
Debra Hoffmeyer, founder and CEO of the C CITrials stated, "Clinical trials play a large role in detecting disease, in understanding the root causes of acute and chronic illnesses, and in discovering medical innovations. Every medicine must be fully vetted through closely monitored and highly regulated clinical trials before it's used in clinical practice. CITrials conducts a scientific study to test the effectiveness of a new treatment or medication in people. With over 40 years in the clinical research field, we have played a vital role in developing and introducing many effective drugs in the market."
About CITrials
Founded in 2000, CITrials conducts Phase I to Phase IV clinical trials to further the development of medications to benefit patients, communities, and physicians. CITrials specializes in mental health trials including those for Schizophrenia, Schizoaffective Disorder, Borderline Personality Disorder, PTSD, Bipolar Disorder, Depression, Hot flashes, Mild Cognitive Impairment, Major Depressive Disorder, Alzheimer's disease, Tourette's, Stuttering, and ADHD for adults and adolescents. CITrials has a great reputation for rapidly producing accurate trial results in accordance to global guideline requirements.
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