Endothelial Facilitation in Alzheimer's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simvastatin + L-Arginine + Tetrahydrobiopterin

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

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Simvastatin, 40 mg per day orally

L-Arginine

Intervention Type DRUG

L-Arginine, 2 Gm four times per day orally;

Tetrahydrobiopterin

Intervention Type DRUG

Tetrahydrobiopterin 20 mg/kg/day orally

Interventions

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Simvastatin

Simvastatin, 40 mg per day orally

Intervention Type DRUG

L-Arginine

L-Arginine, 2 Gm four times per day orally;

Intervention Type DRUG

Tetrahydrobiopterin

Tetrahydrobiopterin 20 mg/kg/day orally

Intervention Type DRUG

Other Intervention Names

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Tetrahydrobiopterin Kuvan Sapropterin

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No