Hanmi Pharmaceutical said that it has presented the phase 4 clinical trial results of Carnitil, a brain function improvement agent, at the 2019 Alzheimer’s Association International Conference (AAIC) held in Los Angeles from July 14-18.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
During the phase 4 clinical study, the researchers administered either donepezil alone or combination therapy of donepezil and Carnitil for 28 weeks on local dementia patients with cerebrovascular disease. Afterward, they compared the changes in the Korean version of the Montreal Cognitive Assessment (MoCA-K) scores.
The company conducted the study at four medical institutions -- Veterans Health Service Medical Center, Korea University Anam Hospital, Hanyang University Guri Hosptial, and Kangbuk Samsung Hospital.
According to the results of the study, the Carnitil combination group showed improvement in the attention and language ability criteria of the MoCA-K. The research also showed improvement in the “Clinical Dementia Rating–Sum of Boxes” (CDR-SB) and the Korean Instrumental Activities of Daily Living (K-IADL).
“MoCA-K is a test used to differentiate frontal lobe function,” said Professor Yang Yung-soon at the conference. “Carnitil has been shown to improve cognitive dysfunction spawning from dementia or cerebrovascular disease, and contribute to maintaining frontal function.”
Hanmi’s Marketing Division Director Park Myung-hee also said, “Although brain function improvement is difficult to prove, the result is meaningful as it demonstrated the drug’s efficacy among Korean patients.”
The company plans to conduct evidence-based marketing encouraged by the results of the trial, Park added.
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