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
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Executive Function | 12 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. |
| Primary | NINDS-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) |
| Secondary | Memory | 12 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. |
| Secondary | Language | 12 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. |
| Secondary | Attention Measured Using Digit Span Backward | 12 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. |
| Secondary | White Matter Lesion Volume | 12 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 |
| Secondary | Cerebral Perfusion | 12 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. |
| Secondary | Attention Measured Using Digit Span Forward | 12 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Executive Function | 12 months | seconds | LEAST_SQUARES_MEAN | |
| PRIMARY | NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or EXAMINER Tool Box. | 12 months | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Memory | 12 months | percentage of retention | LEAST_SQUARES_MEAN | |
| SECONDARY | Language | 12 months | number of correct responses | LEAST_SQUARES_MEAN | |
| SECONDARY | Attention Measured Using Digit Span Backward | 12 months | Number of correct responses | LEAST_SQUARES_MEAN | |
| SECONDARY | White Matter Lesion Volume | 12 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^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Cerebral Perfusion | 12 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/min | LEAST_SQUARES_MEAN |
| SECONDARY | Attention Measured Using Digit Span Forward | 12 months | Number of correct responses | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Executive Function | Candesartan | 87.23 | Standard Error 5.46 | seconds | |
| Executive Function | Lisinopril | 111.37 | Standard Error 5.89 | seconds | |
| NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or EXAMINER Tool Box. | Candesartan | 0.07 | Standard Error 0.07 | units on a scale | |
| NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or EXAMINER Tool Box. | Lisinopril | 0.25 | Standard Error 0.07 | units on a scale | |
| Memory | Candesartan | 82.71 | Standard Error 3.26 | percentage of retention | |
| Memory | Lisinopril | 79.47 | Standard Error 3.39 | percentage of retention | |
| Language | Candesartan | 13.42 | Standard Error 0.18 | number of correct responses | |
| Language | Lisinopril | 13.84 | Standard Error 0.18 | number of correct responses | |
| Attention Measured Using Digit Span Backward | Candesartan | 5.14 | Standard Error 0.25 | Number of correct responses | |
| Attention Measured Using Digit Span Backward | Lisinopril | 5.16 | Standard Error 0.26 | Number of correct responses |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Candesartan | 87 | |
| Overall Study | STARTED | Lisinopril | 89 | |
| Overall Study | COMPLETED | Candesartan | 77 | |
| Overall Study | COMPLETED | Lisinopril | 64 | |
| Overall Study | NOT COMPLETED | Candesartan | 10 | |
| Overall Study | NOT COMPLETED | Lisinopril | 25 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Candesartan | 7 | 87 | 7 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Lisinopril | 24 | 89 | 24 |
| other | Headache | General disorders | Candesartan | 18 | 87 | 18 |
| other | Headache | General disorders | Lisinopril | 22 | 89 | 22 |
| other | Dizziness | General disorders | Candesartan | 15 | 87 | 15 |
| other | Dizziness | General disorders | Lisinopril | 14 | 89 | 14 |
| other | Edema | General disorders | Candesartan | 13 | 87 | 13 |
| other | Edema | General disorders | Lisinopril | 12 | 89 | 12 |
| other | General Pain | General disorders | Candesartan | 7 | 87 | 7 |
| other | General Pain | General disorders | Lisinopril | 9 | 89 | 9 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Candesartan | 0 | 87 |
| Total, all-cause mortality | Lisinopril | 0 | 89 |
| Total, other adverse events | Candesartan | 87 | 87 |
| Total, other adverse events | Lisinopril | 89 | 89 |
| Total, serious adverse events | Candesartan | 0 | 87 |
| Total, serious adverse events | Lisinopril | 0 | 89 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32761160 | DERIVED |
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG042127 | Hypertension angiotensin receptor blockers and cognition: effects and mechanism | HAJJAR, IHAB M | EMORY UNIVERSITY | NATIONAL INSTITUTE ON AGING | 2012 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Candesartan vs Lisinopril: deaths from any cause | Trial comparisons |
| Candesartan vs Lisinopril: serious adverse events | Trial comparisons |
Tests8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Eriksen Flanker Task | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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