Endothelial Facilitation in Alzheimer's Disease

University of Massachusetts, Worcester

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Simvastatin

Drug: Tetrahydrobiopterin

Drug: L-Arginine

Study type

Interventional

Funder types

Other

Identifiers

NCT01439555

13748

Details and patient eligibility

About

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

Enrollment

11 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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.