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Confirmatory Study for AD-810N in Patients with Parkinsonism in Dementia with Lewy Bodies.

Confirmatory Study for AD-810N in Patients with Parkinsonism in Dementia with Lewy Bodies.(Phase 3 study)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222787
Enrollment
300
Registered
2015-03-09
Start date
2015-03-09
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

Parkinsonism in Dementia with Lewy Bodies

Interventions

investigational material(s) Generic name etc : AD-810N INN of investigational material : Zonisamide Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigationa

Sponsors

Sumitomo Dainippon Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients met the diagnostic criteria of probable DLB - Outpatients - Patients taking L-DOPA/DCI in succession more than 12 weeks etc.

Exclusion criteria

Exclusion criteria: - Patients with parkinsonism excepting Dementia with Lewy Bodies - Patients with Parkinson's disease with dementia - Epileptic patients - Patients treated with zonisamide etc.

Design outcomes

Primary

MeasureTime frame
Efficacy : UPDRS Part III total score Change in UPDRS Part III total score

Secondary

MeasureTime frame
Efficacy : MMSE total score, etc Change in MMSE total score, etc

Outcome results

None listed

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