CompletedPhase 3Results posted

A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

Dimebon

Listed sites

118

Recruiting sites

Enrollment

742

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26•AD symptomatic therapy: stable

Primary endpoints

•Abnormal Clinically Significant Vital Signs in Cohort 1•Abnormal Clinically Significant Vital Signs in Cohort 2•Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1

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 IDB1451027

NCT IDNCT00838110

Timeline

Milestones

Study start2009-02 (month precision)

Study first posted2009-02-06estimated

Primary completion2010-01actual (month precision)

Study completion2010-01actual (month precision)

Results first posted2013-02-08estimated

Last update posted2018-12-06actual

Assets

Drug assets

Dimebon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Alzheimer's Disease.

•MMSE 12-26 inclusive.

•If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.

•If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study

Exclusion criteria

•Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).

•Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.

•Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.

•Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.

Endpoints (16)

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

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants With Adverse Events (AEs) in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants With Adverse Events (AEs) in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, event

Primary/registry result

Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 1)Systolic BP (<90 mmHg) (n=127,127)n=127 Participants	0.8	-
Increase in systolic BP (>=30 mmHg) (n=126,124)n=127 Participants	9.5	-
Decrease in systolic BP (>=30 mmHg) (n=126,124)n=127 Participants	16.7	-
Diastolic BP (<50 mmHg) (n=127,127)n=127 Participants	0.8	-
Increase in diastolic BP (>=20 mmHg) (n=126,124)n=127 Participants	7.1	-
Decrease in diastolic BP (>=20 mmHg) (n=126,124)n=127 Participants	15.9	-
Heart rate (>120 bpm) (n=127,127)n=127 Participants	0.0	-
Placebo (Cohort 1)Systolic BP (<90 mmHg) (n=127,127)n=127 Participants	1.6	-
Increase in systolic BP (>=30 mmHg) (n=126,124)n=127 Participants	10.5	-
Decrease in systolic BP (>=30 mmHg) (n=126,124)n=127 Participants	12.9	-
Diastolic BP (<50 mmHg) (n=127,127)n=127 Participants	1.6	-
Increase in diastolic BP (>=20 mmHg) (n=126,124)n=127 Participants	7.3	-
Decrease in diastolic BP (>=20 mmHg) (n=126,124)n=127 Participants	12.9	-
Heart rate (>120 bpm) (n=127,127)n=127 Participants	0.0	-

Primary/registry result

Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 2)Systolic BP (<90 mmHg) (n=243,244)n=243 Participants	0.8	-
Increase in systolic BP (>=30 mmHg) (n=240,240)n=243 Participants	3.8	-
Decrease in systolic BP (>=30 mmHg) (n=240,240)n=243 Participants	9.6	-
Diastolic BP (<50 mmHg) (n=243,244)n=243 Participants	1.2	-
Increase in diastolic BP (>=20 mmHg) (n=240,240)n=243 Participants	6.3	-
Decrease in diastolic BP (>=20 mmHg) (n=240,240)n=243 Participants	6.7	-
Heart rate (>120 bpm) (n=243,244)n=243 Participants	0.0	-
Placebo (Cohort 2)Systolic BP (<90 mmHg) (n=243,244)n=244 Participants	0.0	-
Increase in systolic BP (>=30 mmHg) (n=240,240)n=244 Participants	8.3	-
Decrease in systolic BP (>=30 mmHg) (n=240,240)n=244 Participants	8.8	-
Diastolic BP (<50 mmHg) (n=243,244)n=244 Participants	0.8	-
Increase in diastolic BP (>=20 mmHg) (n=240,240)n=244 Participants	5.4	-
Decrease in diastolic BP (>=20 mmHg) (n=240,240)n=244 Participants	7.5	-
Heart rate (>120 bpm) (n=243,244)n=244 Participants	0.0	-

Primary/registry result

Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 1)PR int (>=300 msec) (n=123,113)n=127 Participants	0.0	-
Increase in PR int (>=25/50%) (n=122,112)n=127 Participants	0.0	-
QRS int (>=200 msec) (n=127,127)n=127 Participants	0.0	-
Increase in QRS int (>=25/50%) (n=126,126)n=127 Participants	1.6	-
QT int (>=500 msec) (n=127,127)n=127 Participants	0.0	-
QTcF int (450 to <480 msec) (n=127,127)n=127 Participants	15.7	-
QTcF int (480 to <500 msec) (n=127,127)n=127 Participants	1.6	-
QTcF int (>=500 msec) (n=127,127)n=127 Participants	0.0	-
Increase in QTcF int (>=30 to <60msec )(n=126,126)n=127 Participants	9.5	-
Increase in QTcF int (>=60 msec) (n=126,126)n=127 Participants	0.8	-
Placebo (Cohort 1)PR int (>=300 msec) (n=123,113)n=127 Participants	0.0	-
Increase in PR int (>=25/50%) (n=122,112)n=127 Participants	0.0	-
QRS int (>=200 msec) (n=127,127)n=127 Participants	0.0	-
Increase in QRS int (>=25/50%) (n=126,126)n=127 Participants	0.0	-
QT int (>=500 msec) (n=127,127)n=127 Participants	2.4	-
QTcF int (450 to <480 msec) (n=127,127)n=127 Participants	13.4	-
QTcF int (480 to <500 msec) (n=127,127)n=127 Participants	4.7	-
QTcF int (>=500 msec) (n=127,127)n=127 Participants	0.8	-
Increase in QTcF int (>=30 to <60msec )(n=126,126)n=127 Participants	7.1	-
Increase in QTcF int (>=60 msec) (n=126,126)n=127 Participants	0.0	-

Primary/registry result

Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 2)PR int (>=300 msec) (n=232,232)n=243 Participants	0.9	-
Increase in PR int (>=25/50%) (n=231,229)n=243 Participants	0.0	-
QRS int (>=200 msec) (n=243,244)n=243 Participants	0.0	-
Increase in QRS int (>=25/50%) (n=242,243)n=243 Participants	0.8	-
QT int (>=500 msec) (n=243,244)n=243 Participants	0.8	-
QTcF int (450 to <480 msec) (n=243,244)n=243 Participants	15.6	-
QTcF int (480 to <500 msec) (n=243,244)n=243 Participants	2.1	-
QTcF int (>=500 msec) (n=243,244)n=243 Participants	1.2	-
Increase in QTcF int (>=30 to <60 msec)(n=242,243)n=243 Participants	6.6	-
Increase in QTcF int (>=60 msec) (n=242,243)n=243 Participants	0.4	-
Placebo (Cohort 2)PR int (>=300 msec) (n=232,232)n=244 Participants	0.0	-
Increase in PR int (>=25/50%) (n=231,229)n=244 Participants	0.0	-
QRS int (>=200 msec) (n=243,244)n=244 Participants	0.0	-
Increase in QRS int (>=25/50%) (n=242,243)n=244 Participants	0.4	-
QT int (>=500 msec) (n=243,244)n=244 Participants	0.8	-
QTcF int (450 to <480 msec) (n=243,244)n=244 Participants	19.3	-
QTcF int (480 to <500 msec) (n=243,244)n=244 Participants	0.8	-
QTcF int (>=500 msec) (n=243,244)n=244 Participants	0.0	-
Increase in QTcF int (>=30 to <60 msec)(n=242,243)n=244 Participants	5.8	-
Increase in QTcF int (>=60 msec) (n=242,243)n=244 Participants	0.0	-

Primary/registry result

Percentage of Participants With Adverse Events (AEs) in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 1)n=127 Participants	64.6	-
Placebo (Cohort 1)n=127 Participants	64.6	-

Primary/registry result

Percentage of Participants With Adverse Events (AEs) in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 2)n=243 Participants	55.1	-
Placebo (Cohort 2)n=244 Participants	53.3	-

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, improvement

Primary/registry result/low confidence

Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1

Time frame:Baseline up to Week 30 (follow-up)

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 1)Hemoglobin (<0.8*LLN) (n=126,123)n=126 Participants	1	-
Red blood cell count (<0.8*LLN) (n=126,123)n=126 Participants	2	-
Mean corpuscular volume (<0.9*LLN) (n=126,123)n=126 Participants	0	-
Mean corpuscular volume (>1.1*ULN) (n=126,123)n=126 Participants	0	-
White blood cell count (<0.6*LLN) (n=126,123)n=126 Participants	0	-
White blood cell count (>1.5*ULN) (n=126,123)n=126 Participants	1	-
Lymphocytes (<0.8*LLN) (n=126,123)n=126 Participants	2	-
Lymphocytes (>1.2*ULN) (n=126,123)n=126 Participants	1	-
Total Neutrophils (<0.8*LLN) (n=126,123)n=126 Participants	0	-
Total Neutrophils (>1.2*ULN) (n=126,123)n=126 Participants	4	-
Monocytes (>1.2*ULN) (n=126,123)n=126 Participants	0	-
Total bilirubin (>1.5*ULN) (n=125,123)n=126 Participants	1	-
Aspartate aminotransferase (>3.0*ULN) (n=125,123)n=126 Participants	1	-
Alanine aminotransferase (>3.0*ULN) (n=125,123)n=126 Participants	1	-
Blood urea nitrogen (>1.3*ULN) (n=125,123)n=126 Participants	1	-
Creatinine (>1.3*ULN) (n=125,123)n=126 Participants	2	-
Sodium (<0.95*LLN) (n=125,123)n=126 Participants	0	-
Sodium (>1.05*ULN) (n=125,123)n=126 Participants	0	-
Potassium (<0.9*LLN) (n=125,123)n=126 Participants	0	-
Potassium (>1.1*ULN) (n=125,123)n=126 Participants	2	-
Calcium (>1.1*ULN) (n=125,123)n=126 Participants	1	-
Magnesium (<0.9*LLN) (n=125,123)n=126 Participants	0	-
Magnesium (>1.1*ULN) (n=125,123)n=126 Participants	20	-
Phosphate (<0.8*LLN) (n=125,123)n=126 Participants	0	-
Phosphate (>1.2*ULN) (n=125,123)n=126 Participants	0	-
Bicarbonate (<0.9*LLN) (n=125,123)n=126 Participants	2	-
Bicarbonate (>1.1*ULN) (n=125,123)n=126 Participants	0	-
Glucose (>1.5*ULN) (n=125,123)n=126 Participants	9	-
Creatine kinase (>2.0*ULN) (n=125,123)n=126 Participants	3	-
Urine specific gravity (<1.003) (n=125,123)n=126 Participants	0	-
Urine specific gravity (>1.030) (n=125,123)n=126 Participants	2	-
Urine pH (>8) (n=125,123)n=126 Participants	0	-
Urine glucose (>=1) (n=125,123)n=126 Participants	4	-
Urine ketones (>=1) (n=125,123)n=126 Participants	1	-
Urine blood (>=1) (n=125,123)n=126 Participants	32	-
Urine protein (>=1) (n=125,123)n=126 Participants	4	-
Placebo (Cohort 1)Hemoglobin (<0.8*LLN) (n=126,123)n=124 Participants	1	-
Red blood cell count (<0.8*LLN) (n=126,123)n=124 Participants	0	-
Mean corpuscular volume (<0.9*LLN) (n=126,123)n=124 Participants	2	-
Mean corpuscular volume (>1.1*ULN) (n=126,123)n=124 Participants	0	-
White blood cell count (<0.6*LLN) (n=126,123)n=124 Participants	1	-
White blood cell count (>1.5*ULN) (n=126,123)n=124 Participants	0	-
Lymphocytes (<0.8*LLN) (n=126,123)n=124 Participants	1	-
Lymphocytes (>1.2*ULN) (n=126,123)n=124 Participants	2	-
Total Neutrophils (<0.8*LLN) (n=126,123)n=124 Participants	1	-
Total Neutrophils (>1.2*ULN) (n=126,123)n=124 Participants	3	-
Monocytes (>1.2*ULN) (n=126,123)n=124 Participants	1	-
Total bilirubin (>1.5*ULN) (n=125,123)n=124 Participants	2	-
Aspartate aminotransferase (>3.0*ULN) (n=125,123)n=124 Participants	0	-
Alanine aminotransferase (>3.0*ULN) (n=125,123)n=124 Participants	1	-
Blood urea nitrogen (>1.3*ULN) (n=125,123)n=124 Participants	2	-
Creatinine (>1.3*ULN) (n=125,123)n=124 Participants	0	-
Sodium (<0.95*LLN) (n=125,123)n=124 Participants	1	-
Sodium (>1.05*ULN) (n=125,123)n=124 Participants	1	-
Potassium (<0.9*LLN) (n=125,123)n=124 Participants	2	-
Potassium (>1.1*ULN) (n=125,123)n=124 Participants	1	-
Calcium (>1.1*ULN) (n=125,123)n=124 Participants	0	-
Magnesium (<0.9*LLN) (n=125,123)n=124 Participants	0	-
Magnesium (>1.1*ULN) (n=125,123)n=124 Participants	24	-
Phosphate (<0.8*LLN) (n=125,123)n=124 Participants	0	-
Phosphate (>1.2*ULN) (n=125,123)n=124 Participants	0	-
Bicarbonate (<0.9*LLN) (n=125,123)n=124 Participants	0	-
Bicarbonate (>1.1*ULN) (n=125,123)n=124 Participants	1	-
Glucose (>1.5*ULN) (n=125,123)n=124 Participants	10	-
Creatine kinase (>2.0*ULN) (n=125,123)n=124 Participants	2	-
Urine specific gravity (<1.003) (n=125,123)n=124 Participants	0	-
Urine specific gravity (>1.030) (n=125,123)n=124 Participants	2	-
Urine pH (>8) (n=125,123)n=124 Participants	1	-
Urine glucose (>=1) (n=125,123)n=124 Participants	3	-
Urine ketones (>=1) (n=125,123)n=124 Participants	2	-
Urine blood (>=1) (n=125,123)n=124 Participants	7	-
Urine protein (>=1) (n=125,123)n=124 Participants	2	-

Primary/registry result/low confidence

Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2

Time frame:Baseline up to Week 16 (follow-up)

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
Dimebon (Cohort 2)Hemoglobin (<0.8*LLN) (n=239,241)n=239 Participants	0	-
Red blood cell count (<0.8*LLN) (n=239,241)n=239 Participants	0	-
Mean corpuscular volume (<0.9*LLN) (n=239,241)n=239 Participants	0	-
Mean corpuscular volume (>1.1*ULN) (n=239,241)n=239 Participants	0	-
White blood cell count (<0.6*LLN) (n=239,241)n=239 Participants	0	-
White blood cell count (>1.5*ULN) (n=239,241)n=239 Participants	0	-
Lymphocytes (<0.8*LLN) (n=239,241)n=239 Participants	1	-
Lymphocytes (>1.2*ULN) (n=239,241)n=239 Participants	3	-
Total Neutrophils (<0.8*LLN) (n=239,241)n=239 Participants	0	-
Total Neutrophils (>1.2*ULN) (n=239,241)n=239 Participants	2	-
Monocytes (>1.2*ULN) (n=239,241)n=239 Participants	0	-
Total bilirubin (>1.5*ULN) (n=239,241)n=239 Participants	0	-
Aspartate aminotransferase (>3.0*ULN) (n=239,241)n=239 Participants	0	-
Alanine aminotransferase (>3.0*ULN) (n=239,241)n=239 Participants	0	-
Blood urea nitrogen (>1.3*ULN) ((n=239,241)n=239 Participants	0	-
Creatinine (>1.3*ULN) (n=239,241)n=239 Participants	0	-
Sodium (<0.95*LLN) (n=239,241)n=239 Participants	0	-
Sodium (>1.05*ULN) (n=239,241)n=239 Participants	0	-
Potassium (<0.9*LLN) (n=239,241)n=239 Participants	0	-
Potassium (>1.1*ULN) (n=239,241)n=239 Participants	0	-
Calcium (>1.1*ULN) (n=239,241)n=239 Participants	0	-
Magnesium (<0.9*LLN) (n=239,241)n=239 Participants	0	-
Magnesium (>1.1*ULN) (n=239,241)n=239 Participants	18	-
Phosphate (<0.8*LLN) (n=239,241)n=239 Participants	0	-
Phosphate (>1.2*ULN) (n=239,241)n=239 Participants	0	-
Bicarbonate (<0.9*LLN) (n=239,241)n=239 Participants	0	-
Bicarbonate (>1.1*ULN) (n=239,241)n=239 Participants	0	-
Glucose (>1.5*ULN) (n=239,241)n=239 Participants	6	-
Creatine kinase (>2.0*ULN) (n=239,241)n=239 Participants	3	-
Urine specific gravity (<1.003) (n=237,240)n=239 Participants	0	-
Urine specific gravity (>1.030) (n=237,240)n=239 Participants	2	-
Urine pH (>8) (n=237,240)n=239 Participants	0	-
Urine glucose (>=1) (n=237,240)n=239 Participants	3	-
Urine ketones (>=1) (n=237,240)n=239 Participants	0	-
Urine blood (>=1) (n=237,240)n=239 Participants	26	-
Urine protein (>=1) (n=237,240)n=239 Participants	1	-
Placebo (Cohort 2)Hemoglobin (<0.8*LLN) (n=239,241)n=241 Participants	0	-
Red blood cell count (<0.8*LLN) (n=239,241)n=241 Participants	0	-
Mean corpuscular volume (<0.9*LLN) (n=239,241)n=241 Participants	0	-
Mean corpuscular volume (>1.1*ULN) (n=239,241)n=241 Participants	0	-
White blood cell count (<0.6*LLN) (n=239,241)n=241 Participants	0	-
White blood cell count (>1.5*ULN) (n=239,241)n=241 Participants	0	-
Lymphocytes (<0.8*LLN) (n=239,241)n=241 Participants	0	-
Lymphocytes (>1.2*ULN) (n=239,241)n=241 Participants	0	-
Total Neutrophils (<0.8*LLN) (n=239,241)n=241 Participants	1	-
Total Neutrophils (>1.2*ULN) (n=239,241)n=241 Participants	1	-
Monocytes (>1.2*ULN) (n=239,241)n=241 Participants	0	-
Total bilirubin (>1.5*ULN) (n=239,241)n=241 Participants	0	-
Aspartate aminotransferase (>3.0*ULN) (n=239,241)n=241 Participants	0	-
Alanine aminotransferase (>3.0*ULN) (n=239,241)n=241 Participants	0	-
Blood urea nitrogen (>1.3*ULN) ((n=239,241)n=241 Participants	0	-
Creatinine (>1.3*ULN) (n=239,241)n=241 Participants	1	-
Sodium (<0.95*LLN) (n=239,241)n=241 Participants	0	-
Sodium (>1.05*ULN) (n=239,241)n=241 Participants	0	-
Potassium (<0.9*LLN) (n=239,241)n=241 Participants	0	-
Potassium (>1.1*ULN) (n=239,241)n=241 Participants	0	-
Calcium (>1.1*ULN) (n=239,241)n=241 Participants	0	-
Magnesium (<0.9*LLN) (n=239,241)n=241 Participants	0	-
Magnesium (>1.1*ULN) (n=239,241)n=241 Participants	17	-
Phosphate (<0.8*LLN) (n=239,241)n=241 Participants	0	-
Phosphate (>1.2*ULN) (n=239,241)n=241 Participants	0	-
Bicarbonate (<0.9*LLN) (n=239,241)n=241 Participants	0	-
Bicarbonate (>1.1*ULN) (n=239,241)n=241 Participants	0	-
Glucose (>1.5*ULN) (n=239,241)n=241 Participants	4	-
Creatine kinase (>2.0*ULN) (n=239,241)n=241 Participants	1	-
Urine specific gravity (<1.003) (n=237,240)n=241 Participants	0	-
Urine specific gravity (>1.030) (n=237,240)n=241 Participants	1	-
Urine pH (>8) (n=237,240)n=241 Participants	0	-
Urine glucose (>=1) (n=237,240)n=241 Participants	3	-
Urine ketones (>=1) (n=237,240)n=241 Participants	0	-
Urine blood (>=1) (n=237,240)n=241 Participants	5	-
Urine protein (>=1) (n=237,240)n=241 Participants	3	-

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.