ConductScience.org, home

Trial · NCT01984164

CAndesartan vs LIsinopril Effects on the BRain

NCT01984164, Phase 2, Completed, Emory University; results first posted 2021-02-21

3 sourcestrials-2026-11-12-0.5.0

Download JSON
Cite this record

ConductScience Library. CAndesartan vs LIsinopril Effects on the BRain. Trials, record NCT01984164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01984164

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
CAndesartan vs LIsinopril Effects on the BRain
NCT number
NCT01984164
Status
Completed
Phases
Phase 2
Enrollment
176 participants, actual
Lead sponsor
Emory University
Conditions
Hypertension, Mild Cognitive Impairment
Interventions
Candesartan, Lisinopril
First posted
2013-11-14
Last updated
2021-02-21
Results first posted
2021-02-21
Limitations and caveats
A limitation of this study is its 1-year study period. Additional limitations include the relatively small sample size, which limited our power to correct for multiple comparisons.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryExecutive Function12 months
Executive function will be assessed using Trail Making Test (part B-A). Part A was collected to correct for motor speed and visual-perceptual demands on TMT by subtracting completion time for TMT Part A from completion time for Part B (TMT B - A). TMT Part B-A provides a relatively purer measure of executive functioning. It has a timed scale from 0 sec (min) to 300 secs (max). Along this scale, a lower score is better.
PrimaryNINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" Tool Box.12 months
EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" tool box. This test batteryThe battery includes 11 tasks that generate 15 primary variables. Within this set, the EXAMINER includes: working memory, inhibition, set shifting, and fluency. The parts of EXAMINER that were used for this study include: Flanker task (inhibition) which involves responding to a central stimulus while ignoring flanking stimuli that are either compatible or incompatible with the central stimulus; Set-shifting, a measure of mental flexibility; Spatial 1-Back test assesses spatial working memory; Dot Counting test assesses verbal working memory; Verbal Fluency tested using a List Generation test which require the participant to generate words beginning with a specific letter, and category fluency in which the participant generates words from a specified category (e.g., animals, fruits). Higher are reflective of better executive function (-1 to +1)
SecondaryMemory12 months
To assess episodic memory, the Hopkins Verbal Learning Test-Revised (HVLT-R) will be used. The retention (%) score is calculated by dividing the delayed recall trial by the higher of 3 learning trials. Each trial scores 0 (min) to 12 (max). The HVLT-R retention score is a percentage, and a higher percentage represents a better outcome.
SecondaryLanguage12 months
This will be measured using the Boston Naming Test. BNT is a neuropsychological test used to assess visual confrontation naming and language performance in participants with cognitive decline. Its short 15-item version consists of drawings of objects ranging from common objects to less familiar objects. Scale: 0 (min score) to 15 (max score). For this test, a higher score/response represents a better outcome.
SecondaryAttention Measured Using Digit Span Backward12 months
The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span backwards, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in reverse order (backward span). Backward span is an executive task particularly dependent on working memory. The Digit Span backward is scored for backwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.
SecondaryWhite Matter Lesion Volume12 months
White Matter Lesion volume: high-resolution anatomical images are acquired for the measurement of microvascular disease. WMH volumes will be obtained from Fluid attenuated inversion recovery (FLAIR) imaging sequence and reported as total volume (in mm3). Higher values means greater WMH
SecondaryCerebral Perfusion12 months
ASL-MRI: Arterial Spin Labeling (ASL) MRI is non-invasive measure of perfusion that does not require contrast, and allows multiple brain regions mapping of perfusion and reserve. ASL-MRI provides measures of cerebral blood flow (CBF). Higher values indicates higher CBF.
SecondaryAttention Measured Using Digit Span Forward12 months
This will be measured using Digit Span Forward. The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span forward, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in the correct order (forward span). Forward span captures attention efficiency and capacity. The Digit Span forward is scored for forwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYExecutive Function12 monthssecondsLEAST_SQUARES_MEAN
PRIMARYNINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or EXAMINER Tool Box.12 monthsunits on a scaleLEAST_SQUARES_MEAN
SECONDARYMemory12 monthspercentage of retentionLEAST_SQUARES_MEAN
SECONDARYLanguage12 monthsnumber of correct responsesLEAST_SQUARES_MEAN
SECONDARYAttention Measured Using Digit Span Backward12 monthsNumber of correct responsesLEAST_SQUARES_MEAN
SECONDARYWhite Matter Lesion Volume12 months
Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.
mm^3LEAST_SQUARES_MEAN
SECONDARYCerebral Perfusion12 months
Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.
ml/100g/minLEAST_SQUARES_MEAN
SECONDARYAttention Measured Using Digit Span Forward12 monthsNumber of correct responsesLEAST_SQUARES_MEAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Executive FunctionCandesartan87.23Standard Error 5.46seconds
Executive FunctionLisinopril111.37Standard Error 5.89seconds
NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or EXAMINER Tool Box.Candesartan0.07Standard Error 0.07units on a scale
NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or EXAMINER Tool Box.Lisinopril0.25Standard Error 0.07units on a scale
MemoryCandesartan82.71Standard Error 3.26percentage of retention
MemoryLisinopril79.47Standard Error 3.39percentage of retention
LanguageCandesartan13.42Standard Error 0.18number of correct responses
LanguageLisinopril13.84Standard Error 0.18number of correct responses
Attention Measured Using Digit Span BackwardCandesartan5.14Standard Error 0.25Number of correct responses
Attention Measured Using Digit Span BackwardLisinopril5.16Standard Error 0.26Number of correct responses

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCandesartan87
Overall StudySTARTEDLisinopril89
Overall StudyCOMPLETEDCandesartan77
Overall StudyCOMPLETEDLisinopril64
Overall StudyNOT COMPLETEDCandesartan10
Overall StudyNOT COMPLETEDLisinopril25

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherCoughRespiratory, thoracic and mediastinal disordersCandesartan7877
otherCoughRespiratory, thoracic and mediastinal disordersLisinopril248924
otherHeadacheGeneral disordersCandesartan188718
otherHeadacheGeneral disordersLisinopril228922
otherDizzinessGeneral disordersCandesartan158715
otherDizzinessGeneral disordersLisinopril148914
otherEdemaGeneral disordersCandesartan138713
otherEdemaGeneral disordersLisinopril128912
otherGeneral PainGeneral disordersCandesartan7877
otherGeneral PainGeneral disordersLisinopril9899

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCandesartan087
Total, all-cause mortalityLisinopril089
Total, other adverse eventsCandesartan8787
Total, other adverse eventsLisinopril8989
Total, serious adverse eventsCandesartan087
Total, serious adverse eventsLisinopril089

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
32761160DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01AG042127Hypertension angiotensin receptor blockers and cognition: effects and mechanismHAJJAR, IHAB MEMORY UNIVERSITYNATIONAL INSTITUTE ON AGING2012 to 2017

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Candesartan vs Lisinopril: deaths from any causeTrial comparisons
Candesartan vs Lisinopril: serious adverse eventsTrial comparisons

Tests8

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
1-Back TaskPrimary outcomeConductCognition
Category FluencyPrimary outcomeConductCognition
Eriksen Flanker TaskPrimary outcomeConductCognition
Trail Making Test BPrimary outcomeConductCognition
Verbal FluencyPrimary outcomeConductCognition
Digit Span TestSecondary outcomeConductCognition
Picture Naming TestSecondary outcomeConductCognition
Verbal LearningSecondary outcomeConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01984164

GET https://conductscience.org/api/trials/v1/NCT01984164/events?page=2