Trial Outcomes & Findings for The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease (NCT NCT00548145)

Results Overview

Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

baseline and 12 months

Results posted on

2012-06-14

Participant Flow

Hyperlipidemia patients with mild to moderate Alzheimer's disease(MMSE15～23)

Participant milestones

Participant milestones
Measure	Pitavastatin 2 mg by orally/day Duration: 12 months	Cholesterol-lowering Medicine Other Than Statin duration: 12 months
Overall Study STARTED	18	20
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Pitavastatin 2 mg by orally/day Duration: 12 months	Cholesterol-lowering Medicine Other Than Statin duration: 12 months
Overall Study Death	0	1
Overall Study Withdrawal by Subject	0	2
Overall Study Physician Decision	1	1

Baseline Characteristics

The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pitavastatin n=18 Participants 2 mg by orally/day Duration: 12 months	Cholesterol-lowering Medicine Other Than Statin n=20 Participants duration: 12 months	Total n=38 Participants Total of all reporting groups
Age Continuous	75.8 years STANDARD_DEVIATION 7.2 • n=5 Participants	75.3 years STANDARD_DEVIATION 7.7 • n=7 Participants	75.5 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 months

Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.

Outcome measures

Outcome measures
Measure	Pitavastatin n=17 Participants 2 mg by orally/day Duration: 12 months	Cholesterol-lowering Medicine Other Than Statin n=16 Participants duration: 12 months
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) baseline	18.59 scores on a scale Standard Deviation 6.13	19.50 scores on a scale Standard Deviation 5.61
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) 12month	20.20 scores on a scale Standard Deviation 9.31	20.59 scores on a scale Standard Deviation 7.91

SECONDARY outcome

Timeframe: baseline and 12 months

Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)

Outcome measures

Outcome data not reported

Adverse Events

Pitavastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cholesterol-lowering Medicine Other Than Statin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hiroaki Kazui,Ph.D.

Osaka University Hospital

Phone: 81-6-6879-3051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER