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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
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
 Drug: Simvastatin + L-Arginine + Tetrahydrobiopterin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Psychometric evaluation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Comparison of baseline psychometric performance with outcome at end of 4 month study


Estimated Enrollment: 10
Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439555

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

Locations
United States, Massachusetts
UMass Medical School/ UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: David A Drachman, MD     508-856-3031     David.drachman@umassmed.edu    
Contact: Barbara Glidden, CCRP     774-334-2529     Barbara.Glidden2@umassmemorial.org    
Sub-Investigator: Daniel A Pollen, MD            
Sub-Investigator: Majaz Moonis, MB            
Sub-Investigator: Jiaying Zhang, MD            
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: David A Drachman, MD UMass Medical School
  More Information

No publications provided

Responsible Party: David Drachman, Professor of Neurology, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01439555     History of Changes
Other Study ID Numbers: 13748
Study First Received: September 16, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Early Alzheimer
Mild Cognitive Impairment
Drug treatment
 Cerebral blood flow
Endothelial facilitation
Cognitive improvement

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Simvastatin
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013