← Trials/Trial dossier/NCT02646982

CEDAR

CompletedPhase 2Results posted

Candesartan's Effects on Alzheimer's Disease And Related Biomarkers

Lead sponsor

Emory University

Asset

Candesartan

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MoCA ≤26

Primary endpoints

•Hypotensive Episode•Symptoms of Hypotension•Hypotensive Episodes and Symptoms

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIRB00084574

NCT IDNCT02646982

NihR01AG049752

Timeline

Milestones

Study first posted2016-01-06estimated

Study start2016-06-30

Primary completion2020-08-17actual

Study completion2020-08-17actual

Results first posted2022-09-29actual

Last update posted2022-12-01actual

Assets

Drug assets

Candesartan

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Mild Cognitive Impairment, defined by:

-Subjective memory concern

-Abnormal memory function documented using the Logical Memory subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale-Revised (the maximum score is 25): [<11 for 16 or more years of education; <9 for 8-15 years of education; <6 for <7 years of education]

-Montreal Cognitive Assessment (MoCA) < 26

-Clinical Dementia Rating scale /Memory sum Box score=0.5

-General functional performance sufficiently preserved (Functional Assessment Questionnaire<9)

•Amyloid positivity determined by measuring the amyloid content in the brain. This can be determined by either cerebrospinal fluid (CSF) amyloid level or an amyloid scan (PIB-PET)

Exclusion criteria

•Intolerance to ARBs

•Current use of ARBs, angiotensin-converting enzyme inhibitors (ACEIs) (use of antihypertensive medications other than ACEI or ARBs for other indications is allowed)

•Current diagnosis of hypertension or current use of antihypertensive medication that is prescribed specifically for hypertensive therapy

•SBP less than 110 or DBP less than 40 mm Hg

•Renal disease (Creatinine >2.0 mg/dl), hyperkalemia (K>5.5 meq/dl), platelets<50,000/μl, or international normalized ratio (INR)>1.9

•Active medical or psychiatric diseases that in the judgment of the investigator would affect the safety of the subject or scientific integrity of the study

•Uncontrolled congestive heart failure reflected by poor exercise tolerance and shortness of breath

•History of stroke in the past 3 years

•Inability to have MRI (eg metal implants or cardiac pacemaker) with an exception for those who cannot have an MRI, if all other parts of the study are obtained successfully they may still be enrolled in the study, or cognitive assessment or inability to assess amyloid positivity (no lumbar puncture and no amyloid scan)

•History of increased intracranial pressure (ICP) or bleeding diathesis (from disease states or from use of anticoagulants such as warfarin, heparin and related products, rivaroxaban or Xarelto, apixaban or Eliquis, edoxaban or Savaysa, dabigatran or Pradaxa)

•Women of childbearing potential (non-menopausal)

•In those who are unable to demonstrate that they understood the details of the study (ie lack of decisional-capacity to consent), a study partner/surrogate who can sign on their behalf will be required, otherwise they will be excluded

•Current use of Lithium, as candesartan may increase lithium concentration to toxic levels

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Amyloid biomarkers

Neuroimaging

Memory

Executive function / language

Global cognition

Tau biomarkers

Fluid / digital biomarkers

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Clinical Dementia Rating (CDR) Score

Time frame:Baseline, Month 12

descriptive

Secondary/registry result

Clinical Dementia Rating (CDR) Score

Time frame:Baseline, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
CandesartanBaselinen=38 Participants	1.86	0.15
Month 12n=38 Participants	2.18	0.28
PlaceboBaselinen=39 Participants	1.85	0.14
Month 12n=39 Participants	2.21	0.27

Memory

4 endpoints

Secondary/protocol endpoint

EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) Toolbox Composite Score

Time frame:Baseline, Month 6, Month 12

ratio, descriptive

Secondary/protocol endpoint

Hopkins Verbal Learning Test (HVLT) Delayed Recall Score

Time frame:Baseline, Month 6, Month 12

descriptive

Secondary/registry result

EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) Toolbox Composite Score

Time frame:Baseline, Month 6, Month 12

ratio, descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
CandesartanBaselinen=38 Participants	0.03	0.11
Month 6n=38 Participants	0.18	0.14
Month 12n=38 Participants	0.07	0.14
PlaceboBaselinen=39 Participants	-0.05	0.11
Month 6n=39 Participants	0.04	0.14
Month 12n=39 Participants	-0.06	0.14

Secondary/registry result

Hopkins Verbal Learning Test (HVLT) Delayed Recall Score

Time frame:Baseline, Month 6, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), number of words recalled	Standard error
CandesartanBaselinen=38 Participants	4.83	0.53
Month 6n=38 Participants	5.40	0.52
Month 12n=38 Participants	5.10	0.52
PlaceboBaselinen=39 Participants	5.29	0.52
Month 6n=39 Participants	5.08	0.51
Month 12n=39 Participants	5.39	0.51

Executive function / language

4 endpoints

Secondary/protocol endpoint

Trail Making Test (TMT) Part B

Time frame:Baseline, Month 6, Month 12

descriptive

Secondary/protocol endpoint

Trail Making Test (TMT) Part B - A

Time frame:Baseline, Month 6, Month 12

descriptive

Secondary/registry result

Trail Making Test (TMT) Part B

Time frame:Baseline, Month 6, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), seconds	Standard error
CandesartanBaselinen=38 Participants	149.44	14.00
Month 6n=38 Participants	122.04	13.49
Month 12n=38 Participants	148.06	16.01
PlaceboBaselinen=39 Participants	142.93	13.88
Month 6n=39 Participants	152.91	13.35
Month 12n=39 Participants	152.96	15.65

Secondary/registry result

Trail Making Test (TMT) Part B - A

Time frame:Baseline, Month 6, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), seconds	Standard error
CandesartanBaselinen=38 Participants	108.08	14.06
Month 6n=38 Participants	81.59	11.56
Month 12n=38 Participants	103.64	13.90
PlaceboBaselinen=39 Participants	91.56	13.87
Month 6n=39 Participants	102.38	11.45
Month 12n=39 Participants	103.50	13.52

Amyloid biomarkers

8 endpoints

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Amyloid Aβ42 Levels

Time frame:Baseline, Month 12

descriptive

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Amyloid Aβ40 Levels

Time frame:Baseline, Month 12

descriptive

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Amyloid Aβ42/Aβ40 Levels

Time frame:Baseline, Month 12

ratio, descriptive

Secondary/protocol endpoint

Global Standardized Uptake Value Ratio (SUVR) of (11)C-Pittsburgh Compound B ((11)C-PiB)

Time frame:Baseline, 12 Months

ratio, descriptive

Secondary/registry result

Cerebrospinal Fluid (CSF) Amyloid Aβ42 Levels

Time frame:Baseline, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), pg/ml	Standard error
CandesartanBaseline Aβ42n=36 Participants	554.80	34.09
Month 12 Aβ42n=36 Participants	557.60	27.32
PlaceboBaseline Aβ42n=37 Participants	523.03	33.98
Month 12 Aβ42n=37 Participants	476.32	27.43

Secondary/registry result

Cerebrospinal Fluid (CSF) Amyloid Aβ40 Levels

Time frame:Baseline, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), pg/ml	Standard error
CandesartanBaseline Aβ40n=36 Participants	11624.00	625.86
Month 12 Aβ40n=36 Participants	11769.00	571.54
PlaceboBaseline Aβ40n=37 Participants	10802.00	623.82
Month 12 Aβ40n=37 Participants	9735.00	573.74

Secondary/registry result

Cerebrospinal Fluid (CSF) Amyloid Aβ42/Aβ40 Levels

Time frame:Baseline, Month 12

ratio, descriptive

Posted result

Group	Value (least_squares_mean), Ratio	Standard error
CandesartanBaseline Aβ42/Aβ40 ration=36 Participants	0.049	0.003
Month 12 Aβ42/Aβ40 ration=36 Participants	0.050	0.003
PlaceboBaseline Aβ42/Aβ40 ration=37 Participants	0.052	0.003
Month 12 Aβ42/Aβ40 ration=37 Participants	0.051	0.003

Secondary/registry result

Global Standardized Uptake Value Ratio (SUVR) of (11)C-Pittsburgh Compound B ((11)C-PiB)

Time frame:Baseline, 12 Months

ratio, descriptive

Posted result

Group	Value (mean), Ratio of target and reference regions	Reported bounds
CandesartanBaselinen=38 Participants	1.32	-1.23 - 1.40
Month 12n=38 Participants	1.34	-1.23 - 1.45
PlaceboBaselinen=39 Participants	1.42	-1.32 - 1.52
Month 12n=39 Participants	1.46	-1.34 - 1.59

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Total Tau Levels

Time frame:Baseline, Month 12

descriptive

Secondary/registry result

Cerebrospinal Fluid (CSF) Total Tau Levels

Time frame:Baseline, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), Picograms per milliliter (pg/ml)	Standard error
CandesartanBaseline Total Taun=36 Participants	638.31	53.61
Month 12 Total Taun=36 Participants	571.96	52.89
PlaceboBaseline Total Taun=37 Participants	529.04	53.50
Month 12 Total Taun=37 Participants	441.25	53.02

Neuroimaging

6 endpoints

Secondary/protocol endpoint

Hippocampal Volume

Time frame:Baseline, Month 12

descriptive

Secondary/protocol endpoint

Vasoreactivity

Time frame:Month 12

change from baseline, improvement

Secondary/protocol endpoint

Global Standardized Uptake Value Ratio (SUVR) of [18F]T807

Time frame:Baseline, 12 Months

ratio, descriptive

Secondary/registry result

Hippocampal Volume

Time frame:Baseline, Month 12

descriptive

Posted result

Group	Value (mean), mm^3	Standard error
CandesartanBaselinen=38 Participants	6949.82	151.66
Month 12n=38 Participants	6761.12	151.42
PlaceboBaselinen=39 Participants	6662.21	151.49
Month 12n=39 Participants	6521.30	152.14

Secondary/registry result

Vasoreactivity

Time frame:Month 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), (ml/100g/min)/mmHg	Reported bounds
Candesartann=38 Participants	0.27	-0.006 - 0.53
Placebon=39 Participants	-0.17	--0.42 - 0.08

Secondary/registry result

Global Standardized Uptake Value Ratio (SUVR) of [18F]T807

Time frame:Baseline, 12 Months

ratio, descriptive

Posted result

Group	Value (mean), Ratio of target and reference regions	Standard error
CandesartanBaselinen=38 Participants	1.33	0.05
Month 12n=38 Participants	1.34	0.06
PlaceboBaselinen=39 Participants	1.36	0.04
Month 12n=39 Participants	1.34	0.05

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) of Tau Phosphorylated at Threonine 181 (p-tau181) Levels

Time frame:Baseline, Month 12

Phosphorylated tau 181 (p-tau181)

descriptive

Secondary/registry result

Cerebrospinal Fluid (CSF) of Tau Phosphorylated at Threonine 181 (p-tau181) Levels

Time frame:Baseline, Month 12

Phosphorylated tau 181 (p-tau181)

descriptive

Posted result

Group	Value (least_squares_mean), pg/ml	Standard error
CandesartanBaseline p-taun=36 Participants	100.29	9.09
Month 12 p-taun=36 Participants	88.52	8.58
PlaceboBaseline p-taun=37 Participants	81.58	9.07
Month 12 p-taun=37 Participants	68.49	8.59

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Number of Participants With a Hypotensive Episode

Time frame:Up to Month 12

event count, event

Primary/registry result

Number of Participants With a Hypotensive Episode

Time frame:Up to Month 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Candesartann=38 Participants	16	-
Placebon=39 Participants	4	-

Other (unclassified)

14 endpoints

Primary/protocol endpoint/low confidence

Number of Participants With Symptoms of Hypotension

Time frame:Up to Month 12

event count, event

Primary/protocol endpoint/low confidence

Number of Participants With Hypotensive Episodes and Symptoms

Time frame:Up to Month 12

event count, event

Primary/protocol endpoint/low confidence

Number of Participants With Elevated Serum Creatinine

Time frame:Up to Month 12

event count, event

Primary/protocol endpoint/low confidence

Number of Participants With Hyperkalemia

Time frame:Up to Month 12

event count, event

Primary/protocol endpoint/low confidence

Number of Participants Discontinuing Study Medication

Time frame:Up to Month 12

event count, event

Primary/registry result/low confidence

Number of Participants With Symptoms of Hypotension

Time frame:Up to Month 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Candesartann=38 Participants	7	-
Placebon=39 Participants	10	-

Primary/registry result/low confidence

Number of Participants With Hypotensive Episodes and Symptoms

Time frame:Up to Month 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Candesartann=38 Participants	4	-
Placebon=39 Participants	1	-

Primary/registry result/low confidence

Number of Participants With Elevated Serum Creatinine

Time frame:Up to Month 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Candesartann=38 Participants	0	-
Placebon=39 Participants	0	-

Primary/registry result/low confidence

Number of Participants With Hyperkalemia

Time frame:Up to Month 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Candesartann=38 Participants	0	-
Placebon=39 Participants	1	-

Primary/registry result/low confidence

Number of Participants Discontinuing Study Medication

Time frame:Up to Month 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Candesartann=38 Participants	0	-
Placebon=39 Participants	1	-

Secondary/protocol endpoint/low confidence

Pulse Wave Velocity (PWV)

Time frame:Baseline, Month 12

descriptive

Secondary/protocol endpoint/low confidence

Augmentation Index (AI)

Time frame:Baseline, Month 12

ratio, descriptive

Secondary/registry result/low confidence

Pulse Wave Velocity (PWV)

Time frame:Baseline, Month 12

descriptive

Posted result

Group	Value (least_squares_mean), m/s	Reported bounds
CandesartanBaselinen=38 Participants	7.81	-7.12 - 8.51
Month 12n=38 Participants	7.71	-7.03 - 8.40
PlaceboBaselinen=39 Participants	8.73	-8.05 - 9.40
Month 12n=39 Participants	8.14	-7.47 - 8.81

Secondary/registry result/low confidence

Augmentation Index (AI)

Time frame:Baseline, Month 12

ratio, descriptive

Posted result

Group	Value (least_squares_mean), percentage of arterial stiffness	Reported bounds
CandesartanBaselinen=38 Participants	29.95	-25.92 - 33.98
Month 12n=38 Participants	28.36	-24.45 - 32.27
PlaceboBaselinen=39 Participants	31.22	-27.24 - 35.20
Month 12n=39 Participants	26.66	-22.81 - 30.51

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Hajjar I, Okafor M, Wan L, Yang Z, Nye JA, Bohsali A, Shaw LM, Levey AI, Lah JJ, Calhoun VD, Moore RH, Goldstein FC. Safety and biomarker effects of candesartan in non-hypertensive adults with prodromal Alzheimer's disease. Brain Commun. 2022 Oct 25;4(6):fcac270. doi: 10.1093/braincomms/fcac270. eCollection 2022.
PMID36440097via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.