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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Simvastatin, 40 mg per day orally
L-Arginine, 2 Gm four times per day orally;
Tetrahydrobiopterin 20 mg/kg/day orally
UMass Medical School/ UMass Memorial Medical Center
Worcester, Massachusetts, United States
Mean Change in Cerebral Blood Flow as Measured by Magnetic Resonance Imaging (MRI)
Measurement of changes to cerebral blood flow (ml/110g/min) in regions of interest as measured using Magnetic Resonance Imaging (MRI)
Time frame: Baseline to 16 weeks
Change in Cerebral Blood Flow as Measured by Arterial Spin Labeling During Magnetic Resonance Imaging (MRI)
Data not available as files corrupted and could not be analyzed
Time frame: Baseline to week 16
Mini Mental State Examination (MMSE) Scores
Change in mental state as reflected by changes to mean Mini Mental State Examination (MMSE) score as measured 4 weeks, 8 weeks and 16 weeks post-baseline. The MMSE uses a 30 point questionnaire to measure cognitive impairment. The MMSE is scored from 0 to 30,with a score equal to or greater than 24 points indicating normal cognition, a score of 19-23 points indicating mild cognitive impairment, 10-18 points indicating moderate impairment and a score equal to or below 9 indicating severe impairment.
Time frame: Baseline to 4 weeks, 8 weeks and 16 weeks post-baseline
Cognitive Assessment Screening Test (CAST)
This outcome measured the change in average Cognitive Assessment Screening Test (CAST) scores for the participant group. The CAST is scored from 0 to 40. A higher score indicates better performance, and a lower score indicates worse performance. The participants were given the CAST at baseline, 4 weeks, 8 weeks and 16 weeks post-baseline. The outcome reports on the averaged change for the averaged CAST scores from baseline to 16 weeks.
Time frame: Baseline to 16 weeks post-baseline
Clinical Dementia Rating Scale (CDR)
This outcome measures Clinical Dementia Rating Scale (CDR) scores at baseline (enrollment) and 16 weeks post-enrollment. The Clinical Dementia Rating Scale is scored with a composite scale of 0 to 3, with higher scores indicating lower functional status and lower scores indicating better functional status.
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Time frame: Baseline to 16 weeks post-baseline
Alzheimer's Disease Assessment Scale: Cognitive and Modified Version (ADAS-COG)
Mean Alzheimer's Disease Assessment Scale: Cognitive Subscale (ADAS-COG) score at baseline and at 16 weeks post-enrollment. The ADAS-COG consists of 11 tasks measuring disturbances of memory, language, praxis, attention and other cognitive abilities. Total scores range from 0 to 70, with higher scores (18 and above) indicating greater cognitive impairment.
Time frame: Baseline to 16 weeks post-baseline
Clinical Interview Based Impression of Change + Caregiver Input (CIBIC Plus)
The Clinical Interview Based Impression of Change + Caregiver Input (CIBIC Plus) is a semi-structured instrument to examine four major areas of patient function: General, Cognitive, Behavioral and Activities of Daily Living. It is scored from 1 to 7. A score of 1 indicates marked improvement, 4 indicates no change and 7 indicates marked worsening.
Time frame: Baseline to 4 weeks, 8 weeks and 16 weeks post-baseline