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Evaluation of the tolerability of rivastigmine patch on patients with Alzheimer's disease

Evaluation of the tolerability of rivastigmine patch on patients with Alzheimer's disease - Evaluation of the tolerability of rivastigmine patch

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012372
Enrollment
144
Registered
2013-11-22
Start date
2013-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer&#39

Interventions

Patients who titrated at 1-week intervals Patients who titrated at 2-week intervals Patients who titrated at 4-week intervals

Sponsors

Graduate School of Medicine, Osaka City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients by whom the concent in the document was got. 2)Patients who are 50 to 85 years old at the assesment of baseline 3)male or female without the possibility of pregnancy 4)Patients diagnosed as dementia of the Alzheimers type by the Diagnostic and Statistical Manual of Mental Disorders 4th edition criteria 5)Patients who diagnosed as probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimers Disease and Related Disorders Association criteria 6)MMSE at baseline of patients are 23 points or less and 10 or more points 7)Patients who were able to do normally reading, writing or spearking till before the onset of dementia 8)Patients who were cooperative and able to undergo medical tests and observation by oneself or with assisit of caregiver 9)Patients who have a caregiver throughout the study. The caregiver was required to be the primary caregiver and to be willing to accept responsibility for supervising the treatment, assessing the condition of the patient throughout the study and for providing input to efficacy assessments according to protocol requirements.

Exclusion criteria

Exclusion criteria: 1)patents who have the problem of urination 2)patients who have the skin disease 3)patients who have sight and hearing handicaps and an advanced speech impediment 4)patient whom the principal investigator or subinvestigator judged to be unsuitable as an object of this research

Design outcomes

Primary

MeasureTime frame
The evaluation of the safety, tolerability and adverse event(frequency of nausea and vomit, change of dietary intake) of rivastigmine patch in patients who titrated at short interval to the maintenace dose

Secondary

MeasureTime frame
ADAS-J cog MMSE Medication compliance Change of caregiver burden

Countries

Japan

Contacts

Public ContactHiroyuki Shimada

Graduate School of Medicine, Osaka City University Geriatrics and Neurology

h.shimada@med.osaka-cu.ac.jp06-6645-3889

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026