Phase 2 N=11 Treatment

Endothelial Facilitation in Alzheimer's Disease

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01439555 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Mean Change in Cerebral Blood Flow as Measured by Magnetic Resonance Imaging (MRI) — 0.621528; 0.6447692; 0.654822667; 0.579838667 ml/110g/min

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Simvastatin (Drug); L-Arginine (Drug); Tetrahydrobiopterin (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: University of Massachusetts, Worcester
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Cerebral Blood Flow as Measured by Magnetic Resonance Imaging (MRI)	0.621528; 0.6447692; 0.654822667; 0.579838667	—
PRIMARY Change in Cerebral Blood Flow as Measured by Arterial Spin Labeling During Magnetic Resonance Imaging (MRI)	—	—
SECONDARY Mini Mental State Examination (MMSE) Scores	24.2; 25.33; 26; 25.55	—
SECONDARY Cognitive Assessment Screening Test (CAST)	31.4	—
SECONDARY Clinical Dementia Rating Scale (CDR)	0.9; 0.9	—
SECONDARY Alzheimer's Disease Assessment Scale: Cognitive and Modified Version (ADAS-COG)	21.6; 21.9	—
SECONDARY Clinical Interview Based Impression of Change + Caregiver Input (CIBIC Plus)	-.1; .6; -.1	—

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01439555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.