Clinical trial NCT00548145: The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Hypercholesterolemia
Keywords: Pitavastatin
Statins
Donepezil
Alzheimer's Disease
Hypercholesterolemia
ADAS-Jcog
Alzheimer Disease (MMSE 15-23 and CDR1 or 2)
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Kowa Company, Ltd.
First posted: 2007-10-23
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The PIT-ROAD study will include 50 patients who have taken donepezil more than 3 months stably. This study will see how the use of a particular statin medication, pitavastatin, affects ADAS-Jcog score etc. and cholesterol.

Participants will be given a full information of the study and written informed consent should be obtained before entering the study. Participants will take part in 5 visits over the course of 12 months. If participants have taken cholesterol lowering drug, they will have wash-out period at least 4weeks. Participants will undergo 8 tests (ADAS-Jcog etc., baseline and month 12 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits). Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
timeFrame: baseline and 12 months
Secondary outcomes:
measure: 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)
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Osaka University Hospital
name: Hiroaki Kazui, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: