Phase 2
N=53
The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial
Cognitive Impairment · Hypertension · Aging
Bottom Line
View on ClinicalTrials.gov: NCT00605072 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Cognitive Assessment: Trail Making Test Part B — -14; 17; 4 seconds — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- candesartan (Drug); lisinopril (Drug); hydrochlorothiazide (Drug); nifedipine, long acting (Drug); metoprolol, long-acting (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Assessment: Trail Making Test Part B |
-14; 17; 4 | 0.008 sig |
| PRIMARY Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall |
-1; -2; -3 | 0.87 |
| PRIMARY Cognitive Assessment: Forward Digit Span Test |
-0.3; 0.02; -0.04 | 0.79 |
| SECONDARY Blood Pressure Outcome: Systolic BP |
28; 27; 21 | 0.74 |
| SECONDARY Blood Flow Velocity, Sitting |
-0.3; -2.85; 0.35 | 0.81 |
Summary
The purpose of this study is to examine the effects of blood pressure medications on cognition and blood flow in hypertensive elderly patients with cognitive impairment. The hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of further cognitive decline, improved cerebral blood flow and its regulation, and preserved physical function as compared to treatment with a diuretic (HCTZ), independent of blood pressure level.
Eligibility Criteria
Inclusion Criteria
- 60 years or older
- Hypertension
- Cognitive criteria: score either 10 or less out of 15 for the executive clock draw test 1 (CLOX1) or less than or equal to 1 standard deviation from the corresponding age specific mean on the immediate memory subtest
Exclusion Criteria
- Intolerance to ACEI or ARB
- History of congestive heart failure
- History of diabetes mellitus
- History of stroke (less than 6 months)
Data sourced from ClinicalTrials.gov (NCT00605072). 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.