Open-label study to assess efficacy and safety of a single dose (i.v.) of NMA78 in DLB or AD patients and HV

Open-label study to assess efficacy and safety of a single dose (i.v.) of NMA78 in patients with Dementia with Lewy Bodies (DLB) or Alzheimer's Disease (AD) and healthy volunteers (HV)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221473

Enrollment

Registered

2011-06-01

Start date

2011-06-01

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

DLB, AD

Interventions

investigational material(s) Generic name etc : NMA78 INN of investigational material : ioflupane(123I) Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [HV] -Healthy Japanese people. [DLB] -Japanese patients clinically- diagnosed with DLB. [AD] -Japanese patients clinically- diagnosed with AD.

Exclusion criteria

Exclusion criteria: -People using following drugs: cocaine hydrochloride, mazindol, methylphenidate hydrochloride, sertraline hydrochloride. -Patients with hepatic, renal or hematopoietic dysfunction. -People with allergic reaction to alcohol or iodine. -Women who are pregnant, lactating or possibly pregnant.

Design outcomes

Primary

Measure	Time frame
Safety: subjective/objective symptoms, vital signs, electrocardiogram, clinical tests Efficacy: diagnostic accuracy by reading committee	—

Secondary

Measure	Time frame
Efficacy: diagnostic accuracy by medical institutions, interpretation reproducibility, dosage and administration, semiquantitative index	—

Outcome results

None listed

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