Long-Term extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

A Phase IIa, Multicenter, Treatment Assigned, Open-Label, Long-Term Extension Study To Determine Safety, Tolerability And Immunogenicity Of ACC-001 With QS-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease(B2571001)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221374

Enrollment

Registered

2011-02-02

Start date

2011-02-02

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

Alzheimers disease

Interventions

investigational material(s) Generic name etc : ACC-001 INN of investigational material : Vanutide cridificar Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Ad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects randomized under previous 3134K1-2202/2206-JA studies and met all inclusion criteria and none of the exclusion criteria. Screening brain MRI is consistent with the diagnosis of Alzheimer's disease. MMSE score 10 and above.

Exclusion criteria

Exclusion criteria: Significant neurological diseases other than Alzheimer's disease. Brain MRI evidence of Vasogenic Edema during the preceding studies. Clinically significant illness.

Design outcomes

Primary

Measure	Time frame
Treatment Emergent Adverse Events, Vital signs, Weight, Laboratory tests, ECGs, MRI, Physical and Neurological examinations Summary of the evaluation items will be performed with descriptive statistics by treatment group.	—

Secondary

Measure	Time frame
Immunogenicity: (IgG, IgM, IgG subtypes) Efficacy: (ADAS-C0g, DAD, NTB, MMSE) Summary of the change from baseline will be performed by treatment group.	—

Outcome results

None listed

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