Endothelial Facilitation in Alzheimer's Disease
Status: | Completed |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 55 - 85 |
Updated: | 4/5/2019 |
Start Date: | November 2011 |
End Date: | November 2017 |
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.
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
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
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.
We found this trial at
1
site
Worcester, Massachusetts 01655
Phone: 508-856-3031
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