Endothelial Facilitation in Alzheimer's Disease

This study is currently recruiting participants.

Verified February 2013 by University of Massachusetts, Worcester

Sponsor:

Information provided by (Responsible Party):

David Drachman, University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT01439555

First received: September 16, 2011

Last updated: February 25, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2011

Last Updated Date

February 25, 2013

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Increase in regional cerebral blood flow over 4 months on studied medications [ Time Frame: 4 months from baseline ] [ Designated as safety issue: No ]

Measurement of cerebral blood flow by Magnetic Resonance Imaging (MRI)- based Arterial Spin Labeling Cerebral Blood Flow, and Gadolinium Contrast-based cerebral blood flow

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01439555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Psychometric evaluation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Comparison of baseline psychometric performance with outcome at end of 4 month study

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endothelial Facilitation in Alzheimer's Disease

Official Title ^ICMJE

Endothelial Facilitation in Alzheimer's Disease. An Open Label Pilot Study of the Sequential and Cumulative Effects of Simvastatin, L-Arginine, and Sapropterin (Kuvan) on Cerebral Blood Flow and Cognitive Function in Patients With Alzheimer's Disease.

Brief Summary

Purpose of the study: Patients with mild Alzheimer's Disease will be given three different drugs over a 4-month period to try to increase the blood flow to their brains, and improve blood vessel and brain function. Each drug can help to open the blood vessels in the brain, and together they may be more effective than each drug alone. The hypothesis is that small blood vessels secrete substances that maintain the integrity of the brain, and may prevent loss of nerve cells leading to Alzheimer's Disease

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: Simvastatin + L-Arginine + Tetrahydrobiopterin

Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally; Tetrahydrobiopterin 20 mg/kg/day orally

Other Name: Tetrahydrobiopterin- Sapropterin - Kuvan

Study Arm (s)

Active Comparator: Simvastatin + L-Arginine + Tetrahydrobiopterin

Simvastatin, 40 mg per day orally; L-Arginine, 2 Gm four times per day orally; Tetrahydrobiopterin 20 mg/kg/day orally

Intervention: Drug: Simvastatin + L-Arginine + Tetrahydrobiopterin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects must have mild Alzheimer's Disease or Mild Cognitive Impairment (MCI);
age between 55-85;
Mini Mental Status Exam (MMSE) between 15-26;
a caregiver who can provide information, and bring patient to the sessions;
no known allergies to any of the medications to be used;
normal renal function; willingness of patient and spouse/responsible caregiver to participate.

Exclusion Criteria:

Significant Psychiatric disorder;
stroke; current use of any of the test medications (e.g., statin, L-Arginine, Kuvan);
phenylketonuria (PKU) ;
elevated serum phenylalanine level (>10 mg/dL);
allergy to any of the medications; current active malignancy;
renal insufficiency (elevated creatinine above 1.3mg/dl);
abnormal liver function (Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) 2x normal);
other serious disease including coronary insufficiency or congestive heart failure, carotid stenosis greater than 50%, active peptic ulcer, urinary tract or other active infection, cancer (except skin cancer, or 5 years inactive breast or prostate cancer )etc.;
pregnancy; or
inability to come to UMass for follow-up. Subjects may continue to take anticholinesterase drugs for Alzheimer's Disease (Aricept, Exelon, Razadyne) and/or Namenda, if they have been on the drug(s) for at least 3 months. Subjects on levodopa and male subjects taking drugs for erectile dysfunction (Viagra, Cialis, Levitra) are cautioned regarding hypotension.

Gender

Both

Ages

55 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: David A Drachman, MD	508-856-3031	David.drachman@umassmed.edu
Contact: Barbara Glidden, CCRP	774-443-2529	Barbara.Glidden2@umassmemorial.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01439555

Other Study ID Numbers ^ICMJE

13748

Has Data Monitoring Committee

Responsible Party

David Drachman, University of Massachusetts, Worcester

Study Sponsor ^ICMJE

University of Massachusetts, Worcester

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David A Drachman, MD

UMass Medical School

Information Provided By

University of Massachusetts, Worcester

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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