CompletedPhase 2Results posted

Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of CNP520 in Healthy Elderly Subjects

Lead sponsor

Novartis Pharmaceuticals

Asset

Umibecestat

Listed sites

Recruiting sites

Enrollment

124

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 60-80

Primary endpoint

•Non-serious and Serious Adverse Events (AEs) and Deaths

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

Eudract number2013-005576-18

Org study IDCCNP520X2102

NCT IDNCT02576639

Timeline

Milestones

Study start2015-08-10actual

Study first posted2015-10-15estimated

Primary completion2016-03-11actual

Study completion2016-03-11actual

Results first posted2017-05-25actual

Last update posted2017-08-11actual

Assets

Drug assets

Umibecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

Key Inclusion Criteria:

•Healthy status

•Body weight: ≥45kg

•BMI: 18-34 kg/m2

Exclusion criteria

•History or presence of any clinically significant disease of any major system organ class.

•Heavy smoker status

•History /presence of clinically significant neurological or psychiatric disorders

•Any medical condition that might lead to or is associated with any cognitive deficit

•History or presence of severely impaired renal function

Endpoints (24)

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)

Amyloid biomarkers

Fluid / digital biomarkers

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations

Time frame:Day 92

change from baseline, improvement

Secondary/registry result

Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations

Time frame:Day 92

change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	Standard deviation
PlaceboAβ 1-38n=21 Participants	-2.34	6.969
Aβ 1-40n=21 Participants	-2.64	6.598
Aβ 1-42n=21 Participants	-2.58	5.189
CNP520 2 mgAβ 1-38n=22 Participants	-20.55	10.475
Aβ 1-40n=22 Participants	-22.64	9.937
Aβ 1-42n=22 Participants	-23.93	8.987
CNP520 10 mgAβ 1-38n=21 Participants	-62.48	6.202
Aβ 1-40n=21 Participants	-62.89	6.485
Aβ 1-42n=21 Participants	-64.28	6.086
CNP520 35 mgAβ 1-38n=23 Participants	-82.93	4.378
Aβ 1-40n=23 Participants	-83.16	4.227
Aβ 1-42n=23 Participants	-82.35	5.474
CNP520 85 mgAβ 1-38n=20 Participants	-89.5	1.676
Aβ 1-40n=20 Participants	-90.69	1.651
Aβ 1-42n=20 Participants	-89.68	2.32

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Summary of CSF PK Concentrations

Time frame:Days 1, 14, 28, 42, 56, 70 and 91

concentration, descriptive

Secondary/registry result

Summary of CSF PK Concentrations

Time frame:Days 1, 14, 28, 42, 56, 70 and 91

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
CNP520 2 mgDay 1 (n=24,25,26,24)n=25 Participants	0	0
Day 14 (n=3,4,4,4)n=25 Participants	0.166	0.103
Day 28 (n=5,2,7,5)n=25 Participants	0.303	0.0731
Day 42 (n=3,6,5,5)n=25 Participants	0.314	0.0715
Day 56 (n=5,5,2,4)n=25 Participants	0.291	0.0605
Day 70 (n=6,5,6,4)n=25 Participants	0.231	0.149
Day 91 (n=23,21,24,20)n=25 Participants	0.305	0.099
CNP520 10 mgDay 1 (n=24,25,26,24)n=25 Participants	0	0
Day 14 (n=3,4,4,4)n=25 Participants	1.07	0.225
Day 28 (n=5,2,7,5)n=25 Participants	1.48	0.106
Day 42 (n=3,6,5,5)n=25 Participants	1.52	0.6
Day 56 (n=5,5,2,4)n=25 Participants	1.28	0.177
Day 70 (n=6,5,6,4)n=25 Participants	1.04	0.212
Day 91 (n=23,21,24,20)n=25 Participants	1.44	0.431
CNP520 35 mgDay 1 (n=24,25,26,24)n=26 Participants	0	0
Day 14 (n=3,4,4,4)n=26 Participants	3.82	0.868
Day 28 (n=5,2,7,5)n=26 Participants	4.48	1.02
Day 42 (n=3,6,5,5)n=26 Participants	4	1.21
Day 56 (n=5,5,2,4)n=26 Participants	5.03	2.69
Day 70 (n=6,5,6,4)n=26 Participants	4.62	0.753
Day 91 (n=23,21,24,20)n=26 Participants	4.52	0.946
CNP520 85 mgDay 1 (n=24,25,26,24)n=24 Participants	0	0
Day 14 (n=3,4,4,4)n=24 Participants	8.13	2.7
Day 28 (n=5,2,7,5)n=24 Participants	12	4.12
Day 42 (n=3,6,5,5)n=24 Participants	7.47	1.57
Day 56 (n=5,5,2,4)n=24 Participants	8.04	5.69
Day 70 (n=6,5,6,4)n=24 Participants	8.71	0.71
Day 91 (n=23,21,24,20)n=24 Participants	10.4	3.26

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths

Time frame:13 weeks

event count, event

Primary/registry result

Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths

Time frame:13 weeks

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboNon-serious AEsn=24 Participants	18	-
Serious AEsn=24 Participants	0	-
Deathsn=24 Participants	0	-
CNP520 2 mgNon-serious AEsn=25 Participants	19	-
Serious AEsn=25 Participants	0	-
Deathsn=25 Participants	0	-
CNP520 10 mgNon-serious AEsn=25 Participants	22	-
Serious AEsn=25 Participants	0	-
Deathsn=25 Participants	0	-
CNP520 35 mgNon-serious AEsn=26 Participants	20	-
Serious AEsn=26 Participants	1	-
Deathsn=26 Participants	0	-
CNP520 85 mgNon-serious AEsn=24 Participants	18	-
Serious AEsn=24 Participants	0	-
Deathsn=24 Participants	0	-

Secondary/protocol endpoint

Summary of Plasma PK Parameter: Cmax

Time frame:Days 1, 91

concentration, descriptive

Secondary/protocol endpoint

Summary of Plasma PK Parameter: AUCtau

Time frame:Days 1 and 91

concentration, descriptive

Secondary/protocol endpoint

Summary of Plasma PK Parameter: Tmax

Time frame:Days 1 and 91

time to event, event

Secondary/protocol endpoint

Summary of Plasma PK Parameter: T1/2

Time frame:Day 91

concentration, descriptive

Secondary/protocol endpoint

Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)

Time frame:Day 91

concentration, descriptive

Secondary/registry result

Summary of Plasma PK Parameter: Cmax

Time frame:Days 1, 91

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
CNP520 2 mgDay 1 (n=25,25,26,24)n=25 Participants	4.76	2.92
Day 91 (=23,22,24,20)n=25 Participants	16.6	5.51
CNP520 10 mgDay 1 (n=25,25,26,24)n=25 Participants	21.3	6.67
Day 91 (=23,22,24,20)n=25 Participants	81	29.2
CNP520 35 mgDay 1 (n=25,25,26,24)n=26 Participants	75.6	23.4
Day 91 (=23,22,24,20)n=26 Participants	237	65.7
CNP520 85 mgDay 1 (n=25,25,26,24)n=24 Participants	163	47.4
Day 91 (=23,22,24,20)n=24 Participants	602	150

Secondary/registry result

Summary of Plasma PK Parameter: AUCtau

Time frame:Days 1 and 91

concentration, descriptive

Posted result

Group	Value (mean), h*ng/mL	Standard deviation
CNP520 2 mgDay 1 (n=25,25,26,24)n=25 Participants	67.1	60.7
Day 91 (n=23,22,24,20)n=25 Participants	313	117
CNP520 10 mgDay 1 (n=25,25,26,24)n=25 Participants	278	65.7
Day 91 (n=23,22,24,20)n=25 Participants	1500	476
CNP520 35 mgDay 1 (n=25,25,26,24)n=26 Participants	966	214
Day 91 (n=23,22,24,20)n=26 Participants	4450	1090
CNP520 85 mgDay 1 (n=25,25,26,24)n=24 Participants	2300	479
Day 91 (n=23,22,24,20)n=24 Participants	11200	3320

Secondary/registry result

Summary of Plasma PK Parameter: Tmax

Time frame:Days 1 and 91

time to event, event

Posted result

Group	Value (median), hour	Reported bounds
CNP520 2 mgDay 1 (n=25,25,26,24)n=25 Participants	2.5	-2.45 - 9
Day 91 (n=23,22,24,20)n=25 Participants	2.5	-0 - 12.1
CNP520 10 mgDay 1 (n=25,25,26,24)n=25 Participants	2.5	-2.5 - 6.02
Day 91 (n=23,22,24,20)n=25 Participants	2.5	-0 - 12.5
CNP520 35 mgDay 1 (n=25,25,26,24)n=26 Participants	2.5	-2.48 - 9
Day 91 (n=23,22,24,20)n=26 Participants	2.5	-0 - 12
CNP520 85 mgDay 1 (n=25,25,26,24)n=24 Participants	2.5	-2.42 - 12
Day 91 (n=23,22,24,20)n=24 Participants	2.5	-0 - 12

Secondary/registry result

Summary of Plasma PK Parameter: T1/2

Time frame:Day 91

concentration, descriptive

Posted result

Group	Value (mean), hour	Standard deviation
CNP520 2 mgn=23 Participants	150	52.2
CNP520 10 mgn=22 Participants	155	40.9
CNP520 35 mgn=24 Participants	155	33.9
CNP520 85 mgn=20 Participants	160	22

Secondary/registry result

Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)

Time frame:Day 91

concentration, descriptive

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Summary of Plasma PK Parameter: Tlag

Time frame:Days 1 and 91

concentration, descriptive

Secondary/protocol endpoint/low confidence

Summary of PK Parameter: CLss/F

Time frame:Day 91

ratio, descriptive

Secondary/protocol endpoint/low confidence

Summary of Plasma PK Parameter: Racc

Time frame:Day 91

ratio, descriptive

Secondary/protocol endpoint/low confidence

Apparent Volume of Distribution (Vz/F)

Time frame:Day 91

descriptive

Secondary/registry result/low confidence

Summary of Plasma PK Parameter: Tlag

Time frame:Days 1 and 91

concentration, descriptive

Posted result

Group	Value (median), hour	Reported bounds
CNP520 2 mgDay 1 (n=25,25,26,24)n=25 Participants	0.5	-0 - 0.567
Day 91 (n=23,22,24,20)n=25 Participants	0	-0 - 0
CNP520 10 mgDay 1 (n=25,25,26,24)n=25 Participants	0.5	-0 - 2.5
Day 91 (n=23,22,24,20)n=25 Participants	0	-0 - 0
CNP520 35 mgDay 1 (n=25,25,26,24)n=26 Participants	0.5	-0 - 0.55
Day 91 (n=23,22,24,20)n=26 Participants	0	-0 - 0
CNP520 85 mgDay 1 (n=25,25,26,24)n=24 Participants	0	-0 - 2.5
Day 91 (n=23,22,24,20)n=24 Participants	0	-0 - 0

Secondary/registry result/low confidence

Summary of PK Parameter: CLss/F

Time frame:Day 91

ratio, descriptive

Posted result

Group	Value (mean), mL/h	Standard deviation
CNP520 2 mgn=23 Participants	7620	2620
CNP520 10 mgn=22 Participants	7380	2480
CNP520 35 mgn=24 Participants	8460	2790
CNP520 85 mgn=20 Participants	8220	2270

Secondary/registry result/low confidence

Summary of Plasma PK Parameter: Racc

Time frame:Day 91

ratio, descriptive

Posted result

Group	Value (mean), ratio	Standard deviation
CNP520 2 mgn=23 Participants	5.86	2.25
CNP520 10 mgn=22 Participants	5.33	1.05
CNP520 35 mgn=24 Participants	4.75	1.16
CNP520 85 mgn=20 Participants	5.02	1.47

Secondary/registry result/low confidence

Apparent Volume of Distribution (Vz/F)

Time frame:Day 91

descriptive

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.