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Endothelial Facilitation in Alzheimer's Disease | Clinical Trials | Clareo Health

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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.

NCT01439555•University of Massachusetts, Worcester

View on ClinicalTrials.gov

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

Eligibility

Age

55 - 85 years

Sex

ALL

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.

Locations (1)

UMass Medical School/ UMass Memorial Medical Center

Worcester, Massachusetts, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

November 1, 2017

Completion Date

November 1, 2017

Last Updated

July 30, 2019

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Simvastatin

DRUG

L-Arginine

DRUG

Tetrahydrobiopterin

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Endothelial Facilitation in Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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