Trial · NCT02646982
Candesartan's Effects on Alzheimer's Disease And Related Biomarkers
NCT02646982, Phase 2, Completed, Emory University; results first posted 2022-09-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Candesartan's Effects on Alzheimer's Disease And Related Biomarkers. Trials, record NCT02646982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02646982
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Candesartan's Effects on Alzheimer's Disease And Related Biomarkers
- NCT number
- NCT02646982
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Mild Cognitive Impairment
- Interventions
- Placebo, Candesartan
- First posted
- 2016-01-06
- Last updated
- 2022-12-01
- Results first posted
- 2022-09-29
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Hypotensive Episode | Up to Month 12 | Hypotension is defined as blood pressure \<100/40 mm Hg. Blood pressure was measured according to the American Heart Association guidelines with the subject in the sitting position and rested for 5 minutes. An appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference) was used and correct cuff placement (1-2 inches above the brachial pulse on bare arm) was ensured. |
| Primary | Number of Participants With Symptoms of Hypotension | Up to Month 12 | Participants were asked to report any symptoms of hypotension (dizziness, weakness, fatigue and lightheadedness). All participants were given a telephone number to reach physician 24-hours per day to report symptoms they experience. The number of participants reporting symptoms of hypotension is reported here. |
| Primary | Number of Participants With Hypotensive Episodes and Symptoms | Up to Month 12 | The number of participants with reported episodes hypotension as well as symptoms of hypotension. |
| Primary | Number of Participants With Elevated Serum Creatinine | Up to Month 12 | The levels of creatinine were obtained from blood samples. Elevated serum creatinine is defined as levels \>2.5 milligram per deciliter (mg/dL). Elevated serum creatinine is indicative of decreased renal function. |
| Primary | Number of Participants With Hyperkalemia | Up to Month 12 | The levels of potassium were obtained from blood samples. Hyperkalemia is defined as potassium levels \>5.9 milliequivalent per deciliter (meq/dL). Hyperkalemia is an indication of kidney dysfunction. |
| Primary | Number of Participants Discontinuing Study Medication | Up to Month 12 | The number of participants who discontinued the study medication is presented here. |
| Secondary | Cerebrospinal Fluid (CSF) Total Tau Levels | Baseline, Month 12 | CSF total tau (t-tau) levels were analyzed from CSF samples obtained via lumbar puncture. Normal values for t-tau are \< 450 pg/ml. Elevated levels of t-tau indicate worsening disease. |
| Secondary | Cerebrospinal Fluid (CSF) of Tau Phosphorylated at Threonine 181 (p-tau181) Levels | Baseline, Month 12 | CSF levels of p-tau181 were analyzed from CSF samples obtained via lumbar puncture. P-tau181 is a biomarker that is elevated in persons with Alzheimer's disease. Higher values indicate worsening disease. |
| Secondary | Cerebrospinal Fluid (CSF) Amyloid Aβ42 Levels | Baseline, Month 12 | CSF Aβ42 levels were analyzed from CSF samples obtained via lumbar puncture. Aβ42 is a biomarker for Alzheimer's disease and lower values indicate worsening disease and an increased accumulation of amyloid in the brain. |
| Secondary | Cerebrospinal Fluid (CSF) Amyloid Aβ40 Levels | Baseline, Month 12 | CSF Aβ40 levels were analyzed from CSF samples obtained via lumbar puncture. Lower values indicate worsening disease and an increased brain accumulation of amyloid. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Hypotensive Episode | Up to Month 12 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Symptoms of Hypotension | Up to Month 12 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Hypotensive Episodes and Symptoms | Up to Month 12 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Elevated Serum Creatinine | Up to Month 12 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Hyperkalemia | Up to Month 12 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Discontinuing Study Medication | Up to Month 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cerebrospinal Fluid (CSF) Total Tau Levels | Baseline, Month 12 | This analysis includes participants who had CSF samples collected. | Picograms per milliliter (pg/ml) | LEAST_SQUARES_MEAN |
| SECONDARY | Cerebrospinal Fluid (CSF) of Tau Phosphorylated at Threonine 181 (p-tau181) Levels | Baseline, Month 12 | This analysis includes participants who had CSF samples collected. | pg/ml | LEAST_SQUARES_MEAN |
| SECONDARY | Cerebrospinal Fluid (CSF) Amyloid Aβ42 Levels | Baseline, Month 12 | This analysis includes participants who had CSF samples collected. | pg/ml | LEAST_SQUARES_MEAN |
| SECONDARY | Cerebrospinal Fluid (CSF) Amyloid Aβ40 Levels | Baseline, Month 12 | This analysis includes participants who had CSF samples collected. | pg/ml | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Hypotensive Episode | Candesartan | 16 | Participants | ||
| Number of Participants With a Hypotensive Episode | Placebo | 4 | Participants | ||
| Number of Participants With Symptoms of Hypotension | Candesartan | 7 | Participants | ||
| Number of Participants With Symptoms of Hypotension | Placebo | 10 | Participants | ||
| Number of Participants With Hypotensive Episodes and Symptoms | Candesartan | 4 | Participants | ||
| Number of Participants With Hypotensive Episodes and Symptoms | Placebo | 1 | Participants | ||
| Number of Participants With Elevated Serum Creatinine | Candesartan | 0 | Participants | ||
| Number of Participants With Elevated Serum Creatinine | Placebo | 0 | Participants | ||
| Number of Participants With Hyperkalemia | Candesartan | 0 | Participants | ||
| Number of Participants With Hyperkalemia | Placebo | 1 | Participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 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 | 38 | |
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | COMPLETED | Candesartan | 35 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Candesartan | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events24
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 | Dizziness | General disorders | Candesartan | 6 | 38 | |
| other | Dizziness | General disorders | Placebo | 5 | 39 | |
| other | Fatigue, tiredness, weakness | General disorders | Candesartan | 4 | 38 | |
| other | Fatigue, tiredness, weakness | General disorders | Placebo | 4 | 39 | |
| other | Headache | General disorders | Candesartan | 2 | 38 | |
| other | Headache | General disorders | Placebo | 5 | 39 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Candesartan | 2 | 38 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 39 | |
| other | Lightheadedness | General disorders | Candesartan | 1 | 38 | |
| other | Lightheadedness | General disorders | Placebo | 1 | 39 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Candesartan | 0 | 38 |
| Total, all-cause mortality | Placebo | 0 | 39 |
| Total, other adverse events | Candesartan | 20 | 38 |
| Total, other adverse events | Placebo | 17 | 39 |
| Total, serious adverse events | Candesartan | 0 | 38 |
| Total, serious adverse events | Placebo | 0 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36440097 | 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 |
|---|---|---|---|---|---|
| R01AG049752 | A biomarker-driven trial of angiotensin receptor blockers for prodromal Alzheimer | GOLDSTEIN, FELICIA C. | EMORY UNIVERSITY | NATIONAL INSTITUTE ON AGING | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Candesartan vs Placebo: Number of Participants With Elevated Serum Creatinine | Trial comparisons |
| Candesartan vs Placebo: Number of Participants With Hypotensive Episodes and Symptoms | Trial comparisons |
| Candesartan vs Placebo: Number of Participants With Hyperkalemia | Trial comparisons |
| Candesartan vs Placebo: Number of Participants With Symptoms of Hypotension | Trial comparisons |
| Candesartan vs Placebo: Number of Participants With a Hypotensive Episode | Trial comparisons |
| Candesartan vs Placebo: deaths from any cause | Trial comparisons |
| Candesartan vs Placebo: Number of Participants Discontinuing Study Medication | Trial comparisons |
| Candesartan vs Placebo: serious adverse events | Trial comparisons |
Tests6
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 | Secondary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Eriksen Flanker Task | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | 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/NCT02646982
GET https://conductscience.org/api/trials/v1/NCT02646982/registered?page=2