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The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease

The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease - The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005883
Enrollment
100
Registered
2011-09-01
Start date
2011-09-01
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

moderate to severe Alzheimer&#39

Interventions

Group A
At first, donepezil (10mg/day) for 24weeks continuously. Memantine is added at 5mg/day (W13)to 20mg/day at W16 (+5mg/day per every 1 week). As a result, donepezil (10mg/day) +memantine (20mg/day) from
At first, donepezil is fixed at 5mg/day continuously from W1 to W13. And from W14 to W24, donepezil is up to 10mg/day. Memantine start from W1 at 5mg/day and adding up to 20mg/day at W4 (+5mg/day per

Sponsors

YASUJI YAMAMOTO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria:Diagnosed as Alzheimer's disease with DSM-4. Severity of dementia: FAST5-6. Medication: Donepezil 5mg/day >=6 months continuously as stable.

Exclusion criteria

Exclusion criteria: Patients with contraindication for donepezil or/and memantine. Patients who is judged as inappropriate for entry to this study.

Design outcomes

Primary

MeasureTime frame
We will carry out tree contents of SIB, FAST and MMSE for 3 times at every 12 week-point during 24 weeks from the start-point of medication and evaluate the results of usefulness.

Secondary

MeasureTime frame
We will carry out two contents of NPI-D and ADCS-ADL for 3 times at every 12 week-point during 24 weeks from the start-point of medication and evaluate the results of usefulness.

Countries

Japan

Contacts

Public ContactYASUJI YAMAMOTO

Kobe University Graduate School of Medicine Department of Psychiatry

yamay@med.kobe-u.ac.jp078-382-6065

Outcome results

None listed

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