Synopsis of Study Results
Name of Sponsor /Company

Name of Finished ProductName of Active Ingredient
Title of Study
Investigators
Study Centre(s)Publication (reference)
Studied Period

Daiichi Sankyo Co., Ltd.
MEMARY® TABLETS 5 mg, 10 mg, 20 mg
Memantine hydrochloride
Phase III study of SUN Y7017 (memantine hydrochloride) in patientswith moderately severe to severe dementia of the Alzheimer's type
Takashi Asada Total 75 investigators
Tsukuba University Hospital Total 74 centers
None
August 23, 2005 to September 12, 2008

(Date of first subject enrolled todate of last subject completed)

Phase of Development

Objectives

Methodology
Number of Patients (plannedand analyzed)

Diagnosis and Main Criteria
for Inclusion

Test Product, Dose and Modeof Administration, Batch
NumberDuration of Treatment
Reference Therapy, Dose andMode of Administration,
Batch Number
Criteria for Evaluation

Phase IIITo examine the efficacy of 24-week treatment with oral SUN Y7017(memantine hydrochloride) 20 mg once daily after breakfast inpatients with moderately severe to severe dementia of the Alzheimer’stype, using a placebo-controlled, double-blind, parallel-group design,and also to evaluate the safety.
A double-blind, parallel-group study, comparing placebo (Group P)
and memantine hydrochloride 20 mg (Group M)
Planned：200 patients per group, total 400 patients
Analyzed：
Safety analysis set: 432 patients (211 in Group P, 221 in Group M)
Efficacy analysis set: 426 patients (208 in Group P, 218 in Group M)
Target disease：dementia of the Alzheimer’s type
Inclusion criteria：• patients diagnosed with dementia of the Alzheimer’s typeaccording to the DSM-IV criteria, and probable Alzheimer’s
Disease according to the NINCDS-ADRDA criteria.
• patients diagnosed with dementia of the Alzheimer’s type based ona brain CT or MRI scan.
• patients fulfilling both the following requirements: MMSE score
between 5 and 14; FAST stage between 6a and 7a.
• patients aged 50 or over at the time of consent.
Exclusion criteria：• patients with dementia of any other type than dementia of theAlzheimer’s type.
• patients with significant neurological disease or history ofpsychiatric disease not associated with AD.
• patients who have taken memantine hydrochloride or any otherinvestigational drug of memantine hydrochloride.
• patients with a history of severe drug allergy.
• patients with a history of alcoholism or drug abuse.
Memantine hydrochloride 20 mg orally once daily
Batch number：4Y19、4Y22、6606、6609
24 weeks
Placebo orally once daily
Batch number：4Y16、4Y17、6X22、6X23
Primary efficacy endpoints
SIB-J, Modified CIBIC plus-J
Safety endpoints
Adverse events, adverse drug reactions

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Statistical Method

Summary - Conclusion

Date of Report

Efficacy
The efficacy was analyzed using the Full Analysis Set (FAS). The
primary analysis included only patients evaluated for efficacy at Week
24 of treatment (hereinafter, referred to as “the OC [observed cases]analysis”). The level of significance for statistical tests was 5%
two-sided.
SIB-J: In terms of the change in total score from the baseline of thedouble-blind period to Week 24 of treatment (change in total score),
the superiority of Group M to Group P was investigated.
Modified CIBIC plus-J: In terms of overall assessment at Week 24 oftreatment (global change), the superiority of Group M to Group P wasinvestigated.
SafetyIn terms of the incidences of adverse events and adverse reactions,differences between the treatment groups were investigated.
Efficacy
SIB-J: The change in the total score in the OC analysis was −5.18 ±11.66（Mean±SD） in Group P and −0.65 ± 9.74 in Group M, withstatistically significant difference between the two groups by theWilcoxon test (p=0.0001).
Modified CIBIC plus-J: The global change at Week 24 of treatment in
the OC analysis was 4.58 ± 1.01（Mean±SD） in Group P and 4.47 ±1.07 in Group M, with no significant difference between the twogroups by the Mantel test but with the score better in Group M than inGroup P (p=0.3189).
SafetyThe incidences of neither adverse events nor adverse reactions differed
between the two treatment groups.
Feb.14, 2011

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