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Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients

NCT00842920 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2020-01-27

No results posted yet for this study

Summary

Probands with MCI are at high risk to develop Alzheimer´s dementia (AD). Simvastatin may lower the production of Amyloid, a hallmark of AD in the brain. The primary hypothesis of the study is that 60 mg Simvastatin significantly reduces the Clinical Dementia Rating -Sum of boxes (CDR-SOB) in individuals with MCI as compared to MCI receiving placebo or 20 mg Simvastatin

Conditions

Interventions

DRUG

Simvastatin 60 mg

60 mg once daily

DRUG

Placebo

one tablet once daily

DRUG

Simvastatin 20 mg

20 mg once daily

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Isabella Heuser, MD, PhD · Charité-CBF

  • Lutz Frölich, MD · CIMH Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2020-08-31
Completion
2021-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00842920 on ClinicalTrials.gov