Phase 2
Completed N=176
CAndesartan vs LIsinopril Effects on the BRain
Source: ClinicalTrials.gov NCT01984164 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Executive Function — 87.23; 111.37 seconds
Summary
The aim of this study is to conduct a 1-year double blind randomized control trial comparing candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive impairment in their effects on executive function, neuroimaging markers, and vascular indicators.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Executive Function |
87.23; 111.37 | — |
| PRIMARY NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" Tool Box. |
0.07; 0.25 | — |
| SECONDARY Memory |
82.71; 79.47 | — |
| SECONDARY Language |
13.42; 13.84 | — |
| SECONDARY Attention Measured Using Digit Span Backward |
5.14; 5.16 | — |
| SECONDARY White Matter Lesion Volume |
2.68; 5.73 | — |
| SECONDARY Cerebral Perfusion |
45.48; 47.65 | — |
| SECONDARY Attention Measured Using Digit Span Forward |
9.67; 8.93 | — |
Eligibility Criteria
Inclusion Criteria
- age: 55 years or older;
- Hypertension: SBP≥140 mm Hg or DBP≥ 90 mm or receiving antihypertensive medications.
- Executive MCI will be defined using these criteria:
- The Montreal Cognitive Assessment (MoCA) score less than or equal to 26
- Executive dysfunction: A performance at the 10th percentile or below on at least one of four screening tests for executive function: Trail Making Test, Part B (TMT-B), modified Stroop interference, Digit Span and Digit Sequencing, and Letter fluency.
- Minimal Functional limitation as reflected by the Functional Assessment Questionnaire (FAQ)≤7
Exclusion Criteria
- Intolerance to study drugs;
- SBP >200 or DBP >110 mm Hg;
- Renal disease or hyperkalemia
- Active medical or psychiatric problems
- Uncontrolled congestive heart failure;
- History of stroke in the past 3 years;
- Inability to perform the study procedures
- Women of childbearing potential
- diagnosis of dementia
- In those who lack decision capacity, a study surrogate who can sign on their behalf will be required. Since we are enrolling only those with MCI, we anticipate that most participants will have decision capacity
- Current use of Lithium, as most antihypertensive classes may lead to increased lithium toxic levels.
Data sourced from ClinicalTrials.gov (NCT01984164). 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. Informational only — not medical advice.