NCT00548145

Brief Summary

Some studies suggest that statin medications may be effective against Alzheimer's disease. However, this has not been proven. The purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 14, 2012

Completed
Last Updated

June 14, 2012

Status Verified

May 1, 2012

Enrollment Period

3.9 years

First QC Date

October 22, 2007

Results QC Date

December 28, 2011

Last Update Submit

May 14, 2012

Conditions

Alzheimer DiseaseHypercholesterolemia

Keywords

PitavastatinStatinsDonepezilAlzheimer's DiseaseHypercholesterolemiaADAS-JcogAlzheimer Disease (MMSE 15-23 and CDR1 or 2)

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)

    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.

    baseline and 12 months

Secondary Outcomes (1)

  • MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)

    baseline and 12 months

Study Arms (2)

1

EXPERIMENTAL
Drug: Pitavastatin

2

ACTIVE COMPARATOR
Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)

Interventions

PitavastatinDRUG

2 mg by orally/day Duration: 12 months

1
cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)DRUG

duration: 12 months

2

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alzheimer's Disease patients (15 ≤ MMSE total score ≤ 23, CDR "1" or "2")
  • Patients with hypercholesterolemia
  • Patients who have taken donepezil more than 3 months stably
  • Both patients and care-givers must be more than 20 years old

You may not qualify if:

  • Women with pregnancy or breast-feeding
  • Malignant tumor
  • Cerebrovascular disorder or myocardial infarction prior to 12 weeks
  • Heart failure \[New York Heart Association (NYHA) class III or IV\]
  • Hepatic or renal dysfunction
  • Severe hypertension
  • Hypothyroidism, hereditary muscular disease, history of drug-induced myopathy
  • Current involvement in another investigational drug study
  • Alcoholism, drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseHypercholesterolemia

Interventions

pitavastatincolestimide

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Hiroaki Kazui,Ph.D.
Organization
Osaka University Hospital
kazui@psy.med.osaka-u.ac.jp
81-6-6879-3051

Study Officials

  • Hiroaki Kazui, Ph.D.

    Osaka University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.Ph.D

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Study Start

November 1, 2007

Primary Completion

October 1, 2011

Study Completion

March 1, 2012

Last Updated

June 14, 2012

Results First Posted

June 14, 2012

Record last verified: 2012-05

Locations

JP(1)