NCT01439555

Endothelial Facilitation in Alzheimer's Disease

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Simvastatin	Simvastatin, 40 mg per day orally
DRUG	L-Arginine	L-Arginine, 2 Gm four times per day orally;
DRUG	Tetrahydrobiopterin	Tetrahydrobiopterin 20 mg/kg/day orally

Timeline

• Start date: 2011-11-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2011-09-23
• Last updated: 2019-07-30
• Results posted: 2019-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study