View Clinical Trial (Medical Research Study)

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.

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Conditions:		Alzheimer's Disease
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
Study Summary:
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.
NCT ID:		NCT01439555
Primary Contact:		Principal Investigator David A Drachman, MD UMass Medical School David A Drachman, MD Phone: 508-856-3031 Email: David.drachman@umassmed.edu
Backup Contact:		Email: Barbara.Glidden2@umassmemorial.org Barbara Glidden, CCRP Phone: 774-443-2529
Location Contact:		Worcester, Massachusetts 01655 United States David A Drachman, MD Phone: 508-856-3031 Email: David.drachman@umassmed.edu Site Status: Recruiting

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