Status:
COMPLETED
Endothelial Facilitation in Alzheimer's Disease
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
The Glass Foundation
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief Summary
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01439555
Start Date
November 1 2011
End Date
November 1 2017
Last Update
July 30 2019
Active Locations (1)
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1
UMass Medical School/ UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655