TerminatedPhase 3Results posted

Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Asset

AVP-786

Listed sites

227

Recruiting sites

Enrollment

1,197

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 6-26

Primary endpoints

•Treatment-Emergent Adverse Events (TEAEs)•Serious TEAE•Potentially Clinically Significant Laboratory Test Abnormalities

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 ID15-AVP-786-303

Eudract number2017-002455-29

NCT IDNCT02446132

Timeline

Milestones

Study first posted2015-05-18estimated

Study start2015-11-13actual

Primary completion2024-09-06actual

Study completion2024-09-06actual

Last update posted2025-10-15actual

Results first posted2025-10-15actual

Assets

Drug assets

AVP-786

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)

•Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria

•Either out-patients or residents of an assisted-living facility or a skilled nursing home

•Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline

•Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation

•Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline

•Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion criteria

•Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)

•Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator

•Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

Endpoints (36)

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

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Caregiver / quality of life

Global cognition

4 endpoints

Primary/protocol endpoint

Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52

Time frame:Baseline (current study), Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52

Time frame:Baseline (current study), Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
AVP-786 18 mgn=121 Participants	-0.8	4.6
AVP-786 28 mgn=372 Participants	-0.7	4.9
AVP-786 42.63 mgn=366 Participants	-0.1	4.1

Secondary/protocol endpoint

Change From Baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants From Study 17-AVP-786-305 at Week 52

Time frame:Baseline (current study), Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants From Study 17-AVP-786-305 at Week 52

Time frame:Baseline (current study), Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

10 endpoints

Primary/protocol endpoint

Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64

Time frame:Baseline (current study), Week 64

change from baseline, improvement

Primary/registry result

Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64

Time frame:Baseline (current study), Week 64

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
AVP-786 18 mgn=92 Participants	-0.0	0.1
AVP-786 28 mgn=276 Participants	0.0	0.1
AVP-786 42.63 mgn=304 Participants	-0.0	0.1

Secondary/protocol endpoint

Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score at Week 64

Time frame:Baseline (current study), Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) at Week 52

Time frame:Baseline (current study), Week 52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score at Week 64

Time frame:Baseline (current study), Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score at Week 64

Time frame:Baseline (current study), Week 64

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) at Week 52

Time frame:Baseline (current study), Week 52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score at Week 64

Time frame:Baseline (current study), Week 64

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Caregiver / quality of life

6 endpoints

Secondary/protocol endpoint

Change From Baseline in the Patient Global Impression of Change (PGIC) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Dementia Quality of Life (DEMQOL) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Resource Utilization in Dementia (RUD) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Patient Global Impression of Change (PGIC) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Dementia Quality of Life (DEMQOL) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Resource Utilization in Dementia (RUD) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

event count, event

Primary/registry result

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
AVP-786 18 mgn=166 Participants	109	-
AVP-786 28 mgn=516 Participants	304	-
AVP-786 42.63 mgn=509 Participants	292	-

Primary/protocol endpoint

Number of Participants With Serious TEAE

Time frame:From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

event count, event

Primary/registry result

Number of Participants With Serious TEAE

Time frame:From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
AVP-786 18 mgn=166 Participants	22	-
AVP-786 28 mgn=516 Participants	75	-
AVP-786 42.63 mgn=509 Participants	70	-

Primary/protocol endpoint

Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities

Time frame:Baseline (current study) up to 52 weeks

change from baseline, event

Primary/registry result

Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities

Time frame:Baseline (current study) up to 52 weeks

change from baseline, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
AVP-786 18 mgPR Interval Value (males and females): >200 to ≤220 msecn=162 Participants	21	-
PR Interval Value (males and females): >220 to ≤250 msecn=162 Participants	13	-
PR Interval Value (males and females): >250 msecn=162 Participants	5	-
QTcF Value (males): >450 to ≤480 msecn=68 Participants	9	-
QTcF Value (males): >480 to ≤500 msecn=68 Participants	2	-
QTcF Value (females): >470 to ≤485 msecn=94 Participants	3	-
QTcF Value (females): >485 to ≤500 msecn=94 Participants	0	-
QTcF Value (females): >500 msecn=94 Participants	0	-
QTcF Change from Baseline (male and females): ≥30 msecn=162 Participants	18	-
QTcF Change from Baseline (male and females): ≥60 msecn=162 Participants	1	-
AVP-786 28 mgPR Interval Value (males and females): >200 to ≤220 msecn=503 Participants	66	-
PR Interval Value (males and females): >220 to ≤250 msecn=503 Participants	33	-
PR Interval Value (males and females): >250 msecn=503 Participants	13	-
QTcF Value (males): >450 to ≤480 msecn=222 Participants	28	-
QTcF Value (males): >480 to ≤500 msecn=222 Participants	2	-
QTcF Value (females): >470 to ≤485 msecn=282 Participants	12	-
QTcF Value (females): >485 to ≤500 msecn=282 Participants	4	-
QTcF Value (females): >500 msecn=282 Participants	1	-
QTcF Change from Baseline (male and females): ≥30 msecn=504 Participants	64	-
QTcF Change from Baseline (male and females): ≥60 msecn=504 Participants	5	-
AVP-786 42.63 mgPR Interval Value (males and females): >200 to ≤220 msecn=492 Participants	60	-
PR Interval Value (males and females): >220 to ≤250 msecn=492 Participants	28	-
PR Interval Value (males and females): >250 msecn=492 Participants	9	-
QTcF Value (males): >450 to ≤480 msecn=207 Participants	23	-
QTcF Value (males): >480 to ≤500 msecn=207 Participants	1	-
QTcF Value (females): >470 to ≤485 msecn=292 Participants	10	-
QTcF Value (females): >485 to ≤500 msecn=292 Participants	2	-
QTcF Value (females): >500 msecn=292 Participants	1	-
QTcF Change from Baseline (male and females): ≥30 msecn=499 Participants	66	-
QTcF Change from Baseline (male and females): ≥60 msecn=499 Participants	5	-

Primary/protocol endpoint

Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs

Time frame:Baseline (current study) up to 52 weeks

event count, event

Primary/registry result

Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs

Time frame:Baseline (current study) up to 52 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
AVP-786 18 mgSBP: ≤90 and ≥20 decrease from baselinen=164 Participants	5	-
SBP: >180 and ≥20 increase from baselinen=164 Participants	0	-
DBP: ≤50 and ≥15 decrease from baselinen=164 Participants	4	-
DBP: ≥105 and ≥15 increase from baselinen=164 Participants	2	-
HR: ≤50 and ≥15 decrease from baselinen=164 Participants	0	-
HR: ≥120 and ≥15 increase from baselinen=164 Participants	0	-
SBP ≥10 and HR ≥5 increase from baselinen=164 Participants	53	-
DBP ≥5 and HR ≥5 increase from baselinen=164 Participants	61	-
AVP-786 28 mgSBP: ≤90 and ≥20 decrease from baselinen=507 Participants	18	-
SBP: >180 and ≥20 increase from baselinen=507 Participants	6	-
DBP: ≤50 and ≥15 decrease from baselinen=507 Participants	8	-
DBP: ≥105 and ≥15 increase from baselinen=507 Participants	3	-
HR: ≤50 and ≥15 decrease from baselinen=507 Participants	7	-
HR: ≥120 and ≥15 increase from baselinen=507 Participants	4	-
SBP ≥10 and HR ≥5 increase from baselinen=507 Participants	147	-
DBP ≥5 and HR ≥5 increase from baselinen=507 Participants	239	-
AVP-786 42.63 mgSBP: ≤90 and ≥20 decrease from baselinen=509 Participants	14	-
SBP: >180 and ≥20 increase from baselinen=509 Participants	4	-
DBP: ≤50 and ≥15 decrease from baselinen=509 Participants	8	-
DBP: ≥105 and ≥15 increase from baselinen=509 Participants	8	-
HR: ≤50 and ≥15 decrease from baselinen=509 Participants	7	-
HR: ≥120 and ≥15 increase from baselinen=509 Participants	1	-
SBP ≥10 and HR ≥5 increase from baselinen=509 Participants	155	-
DBP ≥5 and HR ≥5 increase from baselinen=509 Participants	225	-

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities

Time frame:Baseline (current study) up to 52 weeks

event count, event

Primary/registry result/low confidence

Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities

Time frame:Baseline (current study) up to 52 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
AVP-786 18 mgAlanine Aminotransferase (units per litre {U/L}): ≥3X ULNn=164 Participants	1	-
Albumin (grams per litre {g/L}): ≤26 g/Ln=164 Participants	3	-
Albumin (g/L): ≥60 g/Ln=164 Participants	1	-
Alkaline Phosphatase (U/L): ≥3X ULNn=164 Participants	1	-
Aspartate Aminotransferase (U/L): ≥3X ULNn=164 Participants	2	-
Bilirubin (micromoles per liter {umol/L}): ≥1.5X ULNn=164 Participants	0	-
Blood Urea Nitrogen (millimoles per liter {mmol/L}): ≥10.71 mmol/Ln=158 Participants	19	-
Calcium (mmol/L): ≤1.75 mmol/Ln=164 Participants	0	-
Calcium (mmol/L): ≥3.0 mmol/Ln=164 Participants	0	-
Carbon Dioxide (mmol/L): >40 mmol/Ln=164 Participants	0	-
Cholesterol (mmol/L): ≥7.77 mmol/Ln=164 Participants	7	-
Creatine Kinase (U/L): ≥3X ULNn=164 Participants	2	-
Creatinine (umol/L): >132.6 umol/Ln=164 Participants	8	-
Gamma Glutamyl Transferase (U/L): ≥60 U/Ln=164 Participants	13	-
Glucose (mmol/L): ≤2.775 mmol/Ln=164 Participants	3	-
Glucose (mmol/L): ≥11.1 mmol/Ln=164 Participants	22	-
Lactate Dehydrogenase (U/L): ≥3X ULNn=164 Participants	0	-
Magnesium (mmol/L): <0.37 mmol/Ln=164 Participants	1	-
Magnesium (mmol/L): >1.23 mmol/Ln=164 Participants	0	-
Potassium (mmol/L): ≤3.0 mmol/Ln=164 Participants	2	-
Potassium (mmol/L): ≥5.5 mmol/Ln=164 Participants	6	-
Protein (g/L): ≤50 g/Ln=164 Participants	3	-
Sodium (mmol/L): ≤130 mmol/Ln=164 Participants	6	-
Sodium (mmol/L): ≥155 mmol/Ln=164 Participants	0	-
Triglycerides (mmol/L): >3.39 mmol/Ln=164 Participants	25	-
Uric Acid (umol/L) (Female): ≥505.58 umol/Ln=94 Participants	3	-
Uric Acid (umol/L) (Male): ≥624.54 umol/Ln=70 Participants	0	-
Basophils (10^9/L): >0.3 x10^9/Ln=164 Participants	0	-
Eosinophils/Leukocytes (%): ≥10 %n=164 Participants	12	-
Erythrocytes (10^12/L): ≤2.5 x10^12/Ln=164 Participants	0	-
Erythrocytes (10^12/L): ≥7.0 x10^12/Ln=164 Participants	0	-
Hematocrit (%): <0.3 proportion of 1.0n=164 Participants	4	-
Hematocrit (%): >0.5 proportion of 1.0n=164 Participants	11	-
Hemoglobin (g/L): <100 g/Ln=164 Participants	5	-
Hemoglobin (g/L): >180 g/Ln=164 Participants	0	-
Leukocytes (10^9/L): ≤2.8 x10^9/Ln=164 Participants	2	-
Leukocytes (10^9/L):≥16 x10^9/Ln=164 Participants	2	-
Lymphocytes (10^9/L): ≤0.5 x10^9/Ln=164 Participants	0	-
Lymphocytes (10^9/L): >4 x10^9/Ln=164 Participants	1	-
Lymphocytes/Leukocytes (%): ≤10 %n=164 Participants	6	-
Lymphocytes/Leukocytes (%): ≥60 %n=164 Participants	0	-
Monocytes (10^9/L): >1 x10^9/Ln=164 Participants	7	-
Monocytes/Leukocytes (%): ≥15 %n=164 Participants	5	-
Neutrophils/Leukocytes (%): ≤15 %n=164 Participants	0	-
Platelets (10^9/L): ≤100 x10^9/Ln=164 Participants	2	-
Platelets (10^9/L): ≥700 x10^9/Ln=164 Participants	0	-
AVP-786 28 mgAlanine Aminotransferase (units per litre {U/L}): ≥3X ULNn=510 Participants	0	-
Albumin (grams per litre {g/L}): ≤26 g/Ln=510 Participants	1	-
Albumin (g/L): ≥60 g/Ln=510 Participants	0	-
Alkaline Phosphatase (U/L): ≥3X ULNn=510 Participants	0	-
Aspartate Aminotransferase (U/L): ≥3X ULNn=510 Participants	0	-
Bilirubin (micromoles per liter {umol/L}): ≥1.5X ULNn=510 Participants	2	-
Blood Urea Nitrogen (millimoles per liter {mmol/L}): ≥10.71 mmol/Ln=450 Participants	78	-
Calcium (mmol/L): ≤1.75 mmol/Ln=508 Participants	1	-
Calcium (mmol/L): ≥3.0 mmol/Ln=508 Participants	1	-
Carbon Dioxide (mmol/L): >40 mmol/Ln=510 Participants	0	-
Cholesterol (mmol/L): ≥7.77 mmol/Ln=509 Participants	19	-
Creatine Kinase (U/L): ≥3X ULNn=507 Participants	4	-
Creatinine (umol/L): >132.6 umol/Ln=510 Participants	53	-
Gamma Glutamyl Transferase (U/L): ≥60 U/Ln=501 Participants	52	-
Glucose (mmol/L): ≤2.775 mmol/Ln=510 Participants	9	-
Glucose (mmol/L): ≥11.1 mmol/Ln=510 Participants	71	-
Lactate Dehydrogenase (U/L): ≥3X ULNn=507 Participants	1	-
Magnesium (mmol/L): <0.37 mmol/Ln=505 Participants	1	-
Magnesium (mmol/L): >1.23 mmol/Ln=505 Participants	0	-
Potassium (mmol/L): ≤3.0 mmol/Ln=510 Participants	4	-
Potassium (mmol/L): ≥5.5 mmol/Ln=510 Participants	32	-
Protein (g/L): ≤50 g/Ln=510 Participants	0	-
Sodium (mmol/L): ≤130 mmol/Ln=510 Participants	13	-
Sodium (mmol/L): ≥155 mmol/Ln=510 Participants	1	-
Triglycerides (mmol/L): >3.39 mmol/Ln=508 Participants	61	-
Uric Acid (umol/L) (Female): ≥505.58 umol/Ln=282 Participants	22	-
Uric Acid (umol/L) (Male): ≥624.54 umol/Ln=226 Participants	3	-
Basophils (10^9/L): >0.3 x10^9/Ln=510 Participants	1	-
Eosinophils/Leukocytes (%): ≥10 %n=509 Participants	23	-
Erythrocytes (10^12/L): ≤2.5 x10^12/Ln=510 Participants	0	-
Erythrocytes (10^12/L): ≥7.0 x10^12/Ln=510 Participants	1	-
Hematocrit (%): <0.3 proportion of 1.0n=510 Participants	7	-
Hematocrit (%): >0.5 proportion of 1.0n=510 Participants	31	-
Hemoglobin (g/L): <100 g/Ln=510 Participants	15	-
Hemoglobin (g/L): >180 g/Ln=510 Participants	1	-
Leukocytes (10^9/L): ≤2.8 x10^9/Ln=510 Participants	7	-
Leukocytes (10^9/L):≥16 x10^9/Ln=510 Participants	4	-
Lymphocytes (10^9/L): ≤0.5 x10^9/Ln=510 Participants	4	-
Lymphocytes (10^9/L): >4 x10^9/Ln=510 Participants	8	-
Lymphocytes/Leukocytes (%): ≤10 %n=509 Participants	30	-
Lymphocytes/Leukocytes (%): ≥60 %n=509 Participants	4	-
Monocytes (10^9/L): >1 x10^9/Ln=510 Participants	27	-
Monocytes/Leukocytes (%): ≥15 %n=509 Participants	24	-
Neutrophils/Leukocytes (%): ≤15 %n=509 Participants	1	-
Platelets (10^9/L): ≤100 x10^9/Ln=510 Participants	4	-
Platelets (10^9/L): ≥700 x10^9/Ln=510 Participants	0	-
AVP-786 42.63 mgAlanine Aminotransferase (units per litre {U/L}): ≥3X ULNn=508 Participants	1	-
Albumin (grams per litre {g/L}): ≤26 g/Ln=508 Participants	2	-
Albumin (g/L): ≥60 g/Ln=508 Participants	0	-
Alkaline Phosphatase (U/L): ≥3X ULNn=508 Participants	1	-
Aspartate Aminotransferase (U/L): ≥3X ULNn=507 Participants	0	-
Bilirubin (micromoles per liter {umol/L}): ≥1.5X ULNn=508 Participants	4	-
Blood Urea Nitrogen (millimoles per liter {mmol/L}): ≥10.71 mmol/Ln=398 Participants	63	-
Calcium (mmol/L): ≤1.75 mmol/Ln=508 Participants	0	-
Calcium (mmol/L): ≥3.0 mmol/Ln=508 Participants	0	-
Carbon Dioxide (mmol/L): >40 mmol/Ln=508 Participants	1	-
Cholesterol (mmol/L): ≥7.77 mmol/Ln=508 Participants	18	-
Creatine Kinase (U/L): ≥3X ULNn=505 Participants	4	-
Creatinine (umol/L): >132.6 umol/Ln=508 Participants	26	-
Gamma Glutamyl Transferase (U/L): ≥60 U/Ln=488 Participants	51	-
Glucose (mmol/L): ≤2.775 mmol/Ln=508 Participants	4	-
Glucose (mmol/L): ≥11.1 mmol/Ln=508 Participants	79	-
Lactate Dehydrogenase (U/L): ≥3X ULNn=505 Participants	2	-
Magnesium (mmol/L): <0.37 mmol/Ln=503 Participants	0	-
Magnesium (mmol/L): >1.23 mmol/Ln=503 Participants	1	-
Potassium (mmol/L): ≤3.0 mmol/Ln=507 Participants	2	-
Potassium (mmol/L): ≥5.5 mmol/Ln=507 Participants	34	-
Protein (g/L): ≤50 g/Ln=508 Participants	4	-
Sodium (mmol/L): ≤130 mmol/Ln=508 Participants	12	-
Sodium (mmol/L): ≥155 mmol/Ln=508 Participants	2	-
Triglycerides (mmol/L): >3.39 mmol/Ln=508 Participants	73	-
Uric Acid (umol/L) (Female): ≥505.58 umol/Ln=295 Participants	14	-
Uric Acid (umol/L) (Male): ≥624.54 umol/Ln=213 Participants	3	-
Basophils (10^9/L): >0.3 x10^9/Ln=507 Participants	1	-
Eosinophils/Leukocytes (%): ≥10 %n=505 Participants	33	-
Erythrocytes (10^12/L): ≤2.5 x10^12/Ln=507 Participants	1	-
Erythrocytes (10^12/L): ≥7.0 x10^12/Ln=507 Participants	0	-
Hematocrit (%): <0.3 proportion of 1.0n=507 Participants	9	-
Hematocrit (%): >0.5 proportion of 1.0n=507 Participants	44	-
Hemoglobin (g/L): <100 g/Ln=507 Participants	15	-
Hemoglobin (g/L): >180 g/Ln=507 Participants	3	-
Leukocytes (10^9/L): ≤2.8 x10^9/Ln=507 Participants	3	-
Leukocytes (10^9/L):≥16 x10^9/Ln=507 Participants	5	-
Lymphocytes (10^9/L): ≤0.5 x10^9/Ln=507 Participants	7	-
Lymphocytes (10^9/L): >4 x10^9/Ln=507 Participants	6	-
Lymphocytes/Leukocytes (%): ≤10 %n=505 Participants	21	-
Lymphocytes/Leukocytes (%): ≥60 %n=505 Participants	6	-
Monocytes (10^9/L): >1 x10^9/Ln=507 Participants	23	-
Monocytes/Leukocytes (%): ≥15 %n=505 Participants	23	-
Neutrophils/Leukocytes (%): ≤15 %n=505 Participants	1	-
Platelets (10^9/L): ≤100 x10^9/Ln=507 Participants	6	-
Platelets (10^9/L): ≥700 x10^9/Ln=507 Participants	1	-

Primary/protocol endpoint/low confidence

Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding

Time frame:Baseline (current study), Week 52

event count, event

Primary/registry result/low confidence

Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding

Time frame:Baseline (current study), Week 52

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
AVP-786 18 mgn=166 Participants	2	-
AVP-786 28 mgn=516 Participants	4	-
AVP-786 42.63 mgn=509 Participants	4	-

Primary/protocol endpoint/low confidence

Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Primary/registry result/low confidence

Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52

Time frame:Baseline (current study), Week 52

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
AVP-786 18 mgn=83 Participants	-0.01	4.43
AVP-786 28 mgn=297 Participants	0.07	4.39
AVP-786 42.63 mgn=338 Participants	0.50	3.93

Other/protocol endpoint/low confidence

Number of Participants Using Concomitant Medications

Time frame:Baseline (current study) up to 64 weeks

event count, event

Other_pre_specified/registry result/low confidence

Number of Participants Using Concomitant Medications

Time frame:Baseline (current study) up to 64 weeks

event count, event

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.