← Trials/Trial dossier/NCT02036645

CompletedPhase 1Results posted

SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.

A Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1814 in Subjects With Mild to Moderate Alzheimer's Disease.

Lead sponsor

AstraZeneca

Asset

MEDI1814

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 55-85

Primary endpoint

•Tolerability

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 IDD4750C00001

NCT IDNCT02036645

Timeline

Milestones

Study first posted2014-01-15estimated

Study start2014-02-04actual

Primary completion2016-09-15actual

Study completion2016-09-15actual

Last update posted2019-06-03actual

Results first posted2019-06-03actual

Assets

Drug assets

MEDI1814

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease

Exclusion criteria

History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness

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

Amyloid biomarkers

Fluid / digital biomarkers

Amyloid biomarkers

4 endpoints

Secondary/protocol endpoint

Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)

Time frame:Day 29 in SAD; Day 85 in MAD

percent change from baseline, improvement

Secondary/protocol endpoint

Biomarker: Total Amyloid-beta 1-42 in Plasma

Time frame:Day 29 in SAD; Day 85 in MAD

percent change from baseline, improvement

Secondary/registry result

Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)

Time frame:Day 29 in SAD; Day 85 in MAD

percent change from baseline, improvement

Posted result

Group	Value (mean), % change	Standard deviation
Placebo: SADTotal amyloid-beta 1-40n=12 Participants	122.9	426.51
Total amyloid-beta 1-42n=12 Participants	25.3	100.71
Free amyloid-beta 1-42n=12 Participants	28.6	113.70
Medi1814 25 mg IV: SADTotal amyloid-beta 1-40n=3 Participants	-15.9	20.57
Total amyloid-beta 1-42n=3 Participants	52.0	104.35
Free amyloid-beta 1-42n=3 Participants	-33.9	13.98
Medi1814 100 mg IV: SADTotal amyloid-beta 1-40n=6 Participants	-21.0	19.57
Total amyloid-beta 1-42n=6 Participants	41.7	38.68
Free amyloid-beta 1-42n=6 Participants	-54.3	39.96
Medi1814 300 mg IV: SADTotal amyloid-beta 1-40n=6 Participants	8.72	31.69
Total amyloid-beta 1-42n=6 Participants	192.8	127.96
Free amyloid-beta 1-42n=6 Participants	-57.2	55.80
Medi1814 900 mg IV: SADTotal amyloid-beta 1-40n=6 Participants	2.0	29.21
Total amyloid-beta 1-42n=6 Participants	414.7	292.18
Free amyloid-beta 1-42n=6 Participants	-81.65	21.67
Medi1814 1800 mg IV: SADTotal amyloid-beta 1-40n=6 Participants	10.2	98.14
Total amyloid-beta 1-42n=6 Participants	376.1	295.92
Free amyloid-beta 1-42n=6 Participants	-15.2	189.05
Medi1814 100 mg SC: SADTotal amyloid-beta 1-40n=6 Participants	-14.6	23.69
Total amyloid-beta 1-42n=6 Participants	5.87	24.52
Free amyloid-beta 1-42n=6 Participants	-19.0	17.69
Placebo: MADTotal amyloid-beta 1-40n=8 Participants	4.96	90.19
Total amyloid-beta 1-42n=8 Participants	-29.4	55.90
Free amyloid-beta 1-42n=8 Participants	-2.5	62.66
Medi1814 300 mg IV: MADTotal amyloid-beta 1-40n=6 Participants	638.5	1054.28
Total amyloid-beta 1-42n=6 Participants	633.6	471.79
Free amyloid-beta 1-42n=6 Participants	11.6	167.59
Medi1814 900 mg: MADTotal amyloid-beta 1-40n=6 Participants	-17.9	34.08
Total amyloid-beta 1-42n=6 Participants	197.5	115.25
Free amyloid-beta 1-42n=6 Participants	-96.3	2.26
Medi1814 1800 mg IV: MADTotal amyloid-beta 1-40n=6 Participants	-36.96	46.82
Total amyloid-beta 1-42n=6 Participants	915.5	1361.86
Free amyloid-beta 1-42n=6 Participants	-95.0	1.88
Medi1814 200 mg SC: MADTotal amyloid-beta 1-40n=6 Participants	38.06	47.51
Total amyloid-beta 1-42n=6 Participants	87.8	124.68
Free amyloid-beta 1-42n=6 Participants	-57.7	29.76

Secondary/registry result

Biomarker: Total Amyloid-beta 1-42 in Plasma

Time frame:Day 29 in SAD; Day 85 in MAD

percent change from baseline, improvement

Posted result

Group	Value (mean), % change	Standard deviation
Placebo: SADn=12 Participants	19.6	34.51
Medi1814 25 mg IV: SADn=3 Participants	40132.5	4379.93
Medi1814 100 mg IV: SADn=6 Participants	41107.0	43509.89
Medi1814 300 mg IV: SADn=6 Participants	46667.9	29628.09
Medi1814 900 mg IV: SADn=6 Participants	78534.5	22773.96
Medi1814 1800 mg IV: SADn=6 Participants	44050.9	15776.40
Medi1814 100 mg SC: SADn=6 Participants	45404.0	1808.13
Placebo: MADn=8 Participants	-32.0	45.65
Medi1814 300 mg IV: MADn=6 Participants	30272.4	14834.80
Medi1814 900 mg IV: MADn=6 Participants	84652.8	44649.16
Medi1814 1800 mg IV: MADn=6 Participants	43415.3	13760.07
Medi1814 200 mg SC: MADn=6 Participants	97140.1	34151.47

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Medi1814 Concentration in CSF Samples

Time frame:SAD Day 29; MAD Day 85

concentration, descriptive

Secondary/registry result

Medi1814 Concentration in CSF Samples

Time frame:SAD Day 29; MAD Day 85

concentration, descriptive

Posted result

Group	Value (number), Participants	Reported spread
Medi1814 25 mg IV: SADFirst dose (day 1-29)n=3 Participants	0	0.94
Third dose (day 57-85)n=3 Participants	NA	NA
Medi1814 100 mg IV: SADFirst dose (day 1-29)n=6 Participants	0	2.16
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: SADFirst dose (day 1-29)n=6 Participants	1	2.78
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 900 mg IV: SADFirst dose (day 1-29)n=6 Participants	2	2.23
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 1800 mg IV: SADFirst dose (day 1-29)n=6 Participants	4	7.69
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 100 mg SC: SADFirst dose (day 1-29)n=6 Participants	0	3.56
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	1	1.86
Medi1814 900 mg IV: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	5	1.61
Medi1814 1800 mg IV: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	6	5.38
Medi1814 200 mg SC: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	0	3.29

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

Tolerability as Measured by Participant Withdrawal for an Adverse Event

Time frame:4 months SAD; 7 months MAD

event count, event

Primary/registry result

Tolerability as Measured by Participant Withdrawal for an Adverse Event

Time frame:4 months SAD; 7 months MAD

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
Placebo: SADn=12 Participants	0	-
Medi1814 25 mg IV: SADn=3 Participants	0	-
Medi1814 100 mg IV: SADn=6 Participants	0	-
Medi1814 300 mg IV: SADn=6 Participants	0	-
Medi1814 900 mg IV: SADn=6 Participants	0	-
Medi1814 1800 mg IV: SADn=6 Participants	0	-
Medi1814 100 mg SC : SADn=6 Participants	0	-
Placebo: MADn=8 Participants	0	-
Medi1814 300 mg IV: MADn=6 Participants	0	-
Medi1814 900 mg IV: MADn=6 Participants	0	-
Medi1814 1800 mg IV: MADn=6 Participants	0	-
Medi1814 200 mg SC: MADn=6 Participants	0	-

Secondary/protocol endpoint

Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)

Time frame:1 month

concentration, descriptive

Secondary/protocol endpoint

Maximum Plasma Concentration (Cmax) of Medi1814

Time frame:1 month

concentration, descriptive

Secondary/protocol endpoint

Mean Termination Half Life (t 1/2) of Medi1814

Time frame:1 month

concentration, descriptive

Secondary/protocol endpoint

Immunogenicity: Anti-drug Antibody Titer

Time frame:4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)

descriptive

Secondary/registry result

Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)

Time frame:1 month

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng x day/mL	Geometric coefficient of variation
Medi1814 25 mg IV: SADFirst Dose (day 1-29)n=3 Participants	80.5	61.1
Third dose (day 57-85)n=3 Participants	NA	NA
Medi1814 100 mg IV: SADFirst Dose (day 1-29)n=6 Participants	455	19.7
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: SADFirst Dose (day 1-29)n=6 Participants	1550	26.3
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 900 mg IV: SADFirst Dose (day 1-29)n=6 Participants	4040	28.0
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 1800 mg IV: SADFirst Dose (day 1-29)n=6 Participants	4420	30.7
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 100 mg SC: SADFirst Dose (day 1-29)n=6 Participants	120	51.9
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: MADFirst Dose (day 1-29)n=6 Participants	710	24.2
Third dose (day 57-85)n=6 Participants	1150	37.9
Medi1814 900 mg IV: MADFirst Dose (day 1-29)n=6 Participants	1690	75.3
Third dose (day 57-85)n=6 Participants	2680	74
Medi1814 1800 mg IV: MADFirst Dose (day 1-29)n=6 Participants	4490	24.2
Third dose (day 57-85)n=6 Participants	7150	27.3
Medi1814 200 mg SC: MADFirst Dose (day 1-29)n=6 Participants	162	69.2
Third dose (day 57-85)n=6 Participants	134	57.0

Slope0.9395% CI0.82 - 1.04Regression, Linear

Slope1.0195% CI0.71 - 1.30Regression, Linear

Secondary/registry result

Maximum Plasma Concentration (Cmax) of Medi1814

Time frame:1 month

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/ml	Geometric coefficient of variation
Medi1814 25 mg IV: SADFirst dose (day 1-29)n=3 Participants	10.2	42.7
Third dose (day 57-85)n=3 Participants	NA	NA
Medi1814 100 mg IV: SADFirst dose (day 1-29)n=6 Participants	38.7	30.9
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: SADFirst dose (day 1-29)n=6 Participants	102	14.7
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 900 mg IV: SADFirst dose (day 1-29)n=6 Participants	341	19.3
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 1800 mg IV: SADFirst dose (day 1-29)n=6 Participants	424	36.1
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 100 mg SC: SADFirst dose (day 1-29)n=6 Participants	3.59	51.4
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: MADFirst dose (day 1-29)n=6 Participants	83.9	22.3
Third dose (day 57-85)n=6 Participants	96.7	38.3
Medi1814 900 mg IV: MADFirst dose (day 1-29)n=6 Participants	172	77.2
Third dose (day 57-85)n=6 Participants	185	110
Medi1814 1800 mg IV: MADFirst dose (day 1-29)n=6 Participants	496	24.4
Third dose (day 57-85)n=6 Participants	536	32.3
Medi1814 200 mg SC: MADFirst dose (day 1-29)n=6 Participants	10.1	81.4
Third dose (day 57-85)n=6 Participants	7.56	38.5

Slope0.9095% CI0.81 - 0.98Regression, Linear

Slope0.9695% CI0.65 - 1.27Regression, Linear

Secondary/registry result

Mean Termination Half Life (t 1/2) of Medi1814

Time frame:1 month

concentration, descriptive

Posted result

Group	Value (mean), days	Standard deviation
Medi1814 25 mg IV: SADFirst dose (day 1-29)n=3 Participants	17.2	0.94
Third dose (day 57-85)n=3 Participants	NA	NA
Medi1814 100 mg IV: SADFirst dose (day 1-29)n=6 Participants	17.0	2.16
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: SADFirst dose (day 1-29)n=6 Participants	17.1	2.78
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 900 mg IV: SADFirst dose (day 1-29)n=6 Participants	19.0	2.23
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 1800 mg IV: SADFirst dose (day 1-29)n=6 Participants	18.3	7.69
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 100 mg SC: SADFirst dose (day 1-29)n=6 Participants	19.8	3.56
Third dose (day 57-85)n=6 Participants	NA	NA
Medi1814 300 mg IV: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	14.2	1.86
Medi1814 900 mg IV: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	16.2	1.61
Medi1814 1800 mg IV: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	20.4	5.38
Medi1814 200 mg SC: MADFirst dose (day 1-29)n=6 Participants	NA	NA
Third dose (day 57-85)n=6 Participants	16.4	3.29

Secondary/registry result

Immunogenicity: Anti-drug Antibody Titer

Time frame:4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)

descriptive

Posted result

Group	Value (number), Participants	Reported bounds
Placebo: SADn=12 Participants	0	-
Medi1814 25 mg IV: SADn=3 Participants	0	-
Medi1814 100 mg IV: SADn=6 Participants	0	-
Medi1814 300 mg IV: SADn=6 Participants	0	-
Medi1814 900 mg IV: SADn=6 Participants	0	-
Medi1814 1800 mg IV: SADn=6 Participants	0	-
Medi1814 100 mg SC : SADn=6 Participants	0	-
Placebo: MADn=8 Participants	0	-
Medi1814 300 mg IV: MADn=6 Participants	0	-
Medi1814 900 mg IV: MADn=6 Participants	0	-
Medi1814 1800 mg IV: MADn=6 Participants	0	-
Medi1814 200 mg SC: MADn=6 Participants	0	-

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.