Mild-Moderate Alzheimer's DiseasePhase 1NCT02036645

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

A Phase 1 study testing MEDI1814 for IV injection and MEDI1814 for Subcutaneous Injection in people with Mild-Moderate Alzheimer's Disease and Healthy Elderly, run by AstraZeneca at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people. Read more about this study

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Mild-Moderate Alzheimer's Disease, Healthy Elderly
What is being tested?: MEDI1814 for IV injection and MEDI1814 for Subcutaneous Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 10 sitesUnited States
Study dates: 4 Feb 2014to 15 Sep 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Research Site
Baltimore, Maryland, 21225
Research Site
Glendale, California, 91206
Research Site
Hallandale, Florida, 33009
Research Site
Hialeah, Florida, 33012
Research Site
Long Beach, California, 90806
Research Site
Miami, Florida, 33165
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Orlando, Florida, 32806
Research Site
Panorama City, California, 91402
Research Site
Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: 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.

The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.

Conditions: Mild-Moderate Alzheimer's Disease, Healthy Elderly
Being tested: MEDI1814 for IV injection, MEDI1814 for Subcutaneous Injection, IV Placebo, Placebo for Subcutaneous Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI1814 for IV injectionBiological
Monoclonal antibody for IV Injection
MEDI1814 for Subcutaneous InjectionBiological
Monoclonal antibody for subcutaneous injection
IV PlaceboBiological
Placebo for IV injection
Placebo for Subcutaneous InjectionBiological
Subcutaneous Placebo Injection

Study groups in NCT02036645
Study group	Role	What they receive
MEDI1814 IV	Experimental	Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg. Receives: Biological: MEDI1814 for IV injection
IV Placebo	Placebo comparator	Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg. Receives: Biological: MEDI1814 for IV injection; Biological: IV Placebo
MEDI1814 Sub Cutaneous Injection	Experimental	2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort Receives: Biological: MEDI1814 for Subcutaneous Injection
Subcutaneous Placebo	Placebo comparator	2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort Receives: Biological: Placebo for Subcutaneous Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability as Measured by Participant Withdrawal for an Adverse Event
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
Measured: 4 months SAD; 7 months MAD

Secondary outcomes (7)

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)
Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)
Measured: 1 month
Maximum Plasma Concentration (Cmax) of Medi1814
Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)
Measured: 1 month
Mean Termination Half Life (t 1/2) of Medi1814
Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)
Measured: 1 month
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
Measured: Day 29 in SAD; Day 85 in MAD
Biomarker: Total Amyloid-beta 1-42 in Plasma
Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Measured: Day 29 in SAD; Day 85 in MAD
Medi1814 Concentration in CSF Samples
Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
Measured: SAD Day 29; MAD Day 85
Immunogenicity: Anti-drug Antibody Titer
Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50
Measured: 4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 201415 Sep 2016

First posted15 Jan 2014 (estimated)
Study start4 Feb 2014
Primary completion15 Sep 2016
Study completion15 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mild-Moderate Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02036645
Sponsor's protocol ID: D4750C00001
Status last verified: Feb 2019
First submitted: 13 Jan 2014
Last updated: 3 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT02036645
Acronym / sponsor ID: D4750C00001
Conditions: Mild-Moderate Alzheimer's Disease, Healthy Elderly
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 4 Feb 2014 (actual)
Primary completion: 15 Sep 2016 (actual)
Study completion: 15 Sep 2016 (actual)
First posted: 15 Jan 2014 (estimated)
Results: Posted 3 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
MEDI1814 IV	Experimental	Biological: MEDI1814 for IV injectionUpto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
IV Placebo	Placebo comparator	Biological: MEDI1814 for IV injection, Biological: IV PlaceboUpto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
MEDI1814 Sub Cutaneous Injection	Experimental	Biological: MEDI1814 for Subcutaneous Injection2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Subcutaneous Placebo	Placebo comparator	Biological: Placebo for Subcutaneous Injection2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI1814 for IV injectionMonoclonal antibody for IV Injection	Biological	IV Placebo, MEDI1814 IV
MEDI1814 for Subcutaneous InjectionMonoclonal antibody for subcutaneous injection	Biological	MEDI1814 Sub Cutaneous Injection
IV PlaceboPlacebo for IV injection	Biological	IV Placebo
Placebo for Subcutaneous InjectionSubcutaneous Placebo Injection	Biological	Subcutaneous Placebo

Primary outcome

Tolerability as Measured by Participant Withdrawal for an Adverse Event
Time frame: 4 months SAD; 7 months MAD
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study

7 secondary outcomes

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
Maximum Plasma Concentration (Cmax) of Medi1814
Time frame: 1 month
Mean Termination Half Life (t 1/2) of Medi1814
Time frame: 1 month
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
Biomarker: Total Amyloid-beta 1-42 in Plasma
Time frame: Day 29 in SAD; Day 85 in MAD
Medi1814 Concentration in CSF Samples
Time frame: SAD Day 29; MAD Day 85
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)

Results and safety

Results posted to the registry on 3 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo: SAD	12	12
Medi1814 25 mg IV: SAD	3	3
Medi1814 100 mg IV: SAD	6	6
Medi1814 300 mg IV: SAD	6	5
Medi1814 900 mg IV: SAD	6	6
Medi1814 1800 mg IV: SAD	6	6
Medi1814 100 mg SC: SAD	6	5
Placebo: MAD	0	0
Medi1814 300 mg IV: MAD	0	0
Medi1814 900 mg IV: MAD	0	0
Medi1814 1800 mg IV: MAD	0	0
Medi1814 200 mg SC: MAD	0	0

Primary outcome: Tolerability as Measured by Participant Withdrawal for an Adverse Event

Time frame: 4 months SAD; 7 months MAD. Number. Unit: Participants

Measure	Placebo: SAD n = 12	Medi1814 25 mg IV: SAD n = 3	Medi1814 100 mg IV: SAD n = 6	Medi1814 300 mg IV: SAD n = 6	Medi1814 900 mg IV: SAD n = 6	Medi1814 1800 mg IV: SAD n = 6	Medi1814 100 mg SC : SAD n = 6	Placebo: MAD n = 8	Medi1814 300 mg IV: MAD n = 6	Medi1814 900 mg IV: MAD n = 6	Medi1814 1800 mg IV: MAD n = 6	Medi1814 200 mg SC: MAD n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety Population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline until day 113 (4 months) in SAD Study Part 1; From baseline until day 169 (7 months) in MAD Study Part 2. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo: SAD	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Medi1814 25 mg IV: SAD	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Medi1814 100 mg IV: SAD	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Medi1814 300 mg IV: SAD	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Medi1814 900 mg IV: SAD	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Medi1814 1800 mg IV: SAD	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Medi1814 100 mg SC: SAD	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Placebo: MAD	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Medi1814 300 mg IV: MAD	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Medi1814 900 mg IV: MAD	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Medi1814 1800 mg IV: MAD	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Medi1814 200 mg SC: MAD	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Limitations and caveats (from the sponsor): Although 11 subjects were in both a SAD and a MAD cohort, summaries were for those assigned to the cohort regardless of participation in any other cohort

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thor Ostenfeld, MD study director

AstraZeneca

David Han, MD principal investigator

Glendale Parexel Early Phase Clinical Unit

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability as Measured by Participant Withdrawal for an Adverse Event (time frame: 4 months SAD; 7 months MAD). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.