Endothelial Facilitation in Alzheimer's Disease

Description

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 Start Date

November 2011

Estimated Completion Date

December 2016

Interventions

  • Drug: Simvastatin + L-Arginine + Tetrahydrobiopterin

Specialties

  • Internal Medicine: Clinical Pharmacology,Neurology
  • Neurology: Dementia
  • Pharmacy: Drug Interactions,Drug Trials
  • Physician Assistant: Clinical Pharmacology,Neurology

MeSH Terms

  • Alzheimer Disease
  • L-Arginine
  • Simvastatin
  • Tetrahydrobiopterin

Study ID

University of Massachusetts, Worcester -- 13748

Status

Unknown

Trial ID

NCT01439555

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

10

Sponsor

University of Massachusetts, Worcester

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

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
UMass Medical School UMass Memorial Medical Center - Worcester, Massachusetts 34.2 miles None None None

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