Mild and moderate Alzheimers disease
Conditions
Interventions
(1) Double-blind period
The investigational products are administered as follows according to assignment.
-TW-4752N group: Apply TW-4752N once every 3 days or 4 days.
-Rivastigmine group: Apply one r
Sponsors
Ogawa Koji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Persons who meet the diagnostic criteria for Alzheimer's disease according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders / Diseases (DSM-5) . (2) With a revised Hachinski cerebral ischemia score of 4 points or less. (3) With a baseline ABC dementia scale of 71 to 100. (4) With a baseline MMSE-J score of 10 to 26 points. (5) With a baseline ADAS-Jcog score of 12 to 43 points. (6) Those who have findings consistent with the diagnosis of Alzheimer's disease by imaging examination (CT or MRI) within 24 months before the observation period.
Exclusion criteria
Exclusion criteria: (1) Persons with central nervous system diseases or systemic diseases that affect cognitive function or cognitive function evaluation other than Alzheimer's disease (2) Those who are diagnosed as having abnormal values of serum vitamin B12 or folic acid and affecting cognitive function at the time of screening. (3) Those who are diagnosed as having abnormal values of thyroid stimulating hormone (TSH) or free thyroxine (FT4) and affecting cognitive function at the time of screening. (4) Those who plan to enter a long-term care facility during the observation period and the double-blind period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy:Change from baseline at 24 weeks of double-blind in ADAS-Jcog | — |
Contacts
Public ContactCrinical Department
TOWA PHARMACEUTICAL CO.,LTD.
Outcome results
None listed