Alzheimer's DiseasePhase 1PROPELNCT02434718
Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease
A Phase 1 study testing Aducanumab in people with Alzheimer's Disease, run by Biogen at 7 sites in Japan.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Aducanumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 7 sitesJapan
- Study dates
- 24 Jun 2015to 9 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Must be ambulatory
- Must have a clinical diagnosis of mild to moderate AD
- Must be in good health as determined by the Investigator, based on medical history and Screening assessments
- Must have a caregiver who, understands the study and assents to accompany the subject to all study site visits, provide information to the Investigator/study site staff, specifically about cognitive abilities and AEs/SAEs and return for per-protocol follow-up visits and procedures
- Must consent to blood sample collection for deoxyribonucleic acid (DNA; genotyping) and ribonucleic acid (RNA; for potential future analysis).
Who cannot join
- Any medical or neurological condition (other than AD) that in the opinion of the Investigator could be a contributing cause of the subject's dementia
- Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
- Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within the 3 months prior to Day 1
- History of unstable angina, myocardial infarction, chronic heart failure
- Chronic, uncontrolled hypertension
- History of seizure within 3 years prior to Screening
Show all 9Show fewer
- History within the past 6 months or evidence of clinically significant psychiatric illness
- History of severe allergic or anaphylactic reactions, or history of hypersensitivity to any of the inactive ingredients in the drug product
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Research Site
Kamakura, Kanagawa
Research Site
Kanzaki, Saga-ken
Research Site
Kobe, Hyōgo
Research Site
Kodaira, Tokoyo
Research Site
Kyoto
Research Site
Shinjuku, Tokoyo
Research Site
Tōon, Ehime
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Aducanumab (BIIB037) in Japanese Subjects With Mild to Moderate Alzheimer's Disease
The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity.
- Conditions
- Alzheimer's Disease
- Being tested
- Aducanumab, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AducanumabDrug
As described in the treatment arm
PlaceboDrug
IV administration of 0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo Receives: Drug: Aducanumab; Drug: Placebo |
| Cohort 2 | Experimental | IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo Receives: Drug: Aducanumab; Drug: Placebo |
| Cohort 3 | Experimental | IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo Receives: Drug: Aducanumab; Drug: Placebo |
| Cohort 4 | Experimental | IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo Receives: Drug: Aducanumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of adverse events (AE) / serious adverse events(SAE)
Measured: Up to week 42
Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations
Measured: Up to week 42
Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)
Measured: Up to week 42
Secondary outcomes (8)
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)
Measured: Up to 8 weeks post dosing
AUC from time zero to time of the last measurable concentration (AUC0-last)
Measured: Up to 8 weeks post dosing
Maximum observed concentration (Cmax)
Measured: Up to 8 weeks post dosing
Time to Cmax (Tmax)
Measured: Up to 8 weeks post dosing
Elimination half-life (t1/2)
Measured: Up to 8 weeks post dosing
Volume of distribution at steady state (Vss)
Measured: Up to 8 weeks post dosing
Clearance (CL) after a single IV infusion of aducanumab
Measured: Up to 8 weeks post dosing
Incidence of anti-aducanumab antibodies in serum
Measured: Up to week 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start24 Jun 2015
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434718
- Sponsor's protocol ID
- 221AD104
- Acronym
- PROPEL
- Status last verified
- Aug 2020
- First submitted
- 30 Apr 2015
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Aducanumab (BIIB037) in Japanese Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02434718
- Acronym / sponsor ID
- PROPEL / 221AD104
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2015 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Aducanumab, Drug: PlaceboIV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo |
| Cohort 2 | Experimental | Drug: Aducanumab, Drug: PlaceboIV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo |
| Cohort 3 | Experimental | Drug: Aducanumab, Drug: PlaceboIV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo |
| Cohort 4 | Experimental | Drug: Aducanumab, Drug: PlaceboIV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be ambulatory
- Must have a clinical diagnosis of mild to moderate AD
- Must be in good health as determined by the Investigator, based on medical history and Screening assessments
- Must have a caregiver who, understands the study and assents to accompany the subject to all study site visits, provide information to the Investigator/study site staff, specifically about cognitive abilities and AEs/SAEs and return for per-protocol follow-up visits and procedures
- Must consent to blood sample collection for deoxyribonucleic acid (DNA; genotyping) and ribonucleic acid (RNA; for potential future analysis).
Key exclusion criteria (9 listed)
- Any medical or neurological condition (other than AD) that in the opinion of the Investigator could be a contributing cause of the subject's dementia
- Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
- Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within the 3 months prior to Day 1
- History of unstable angina, myocardial infarction, chronic heart failure
- Chronic, uncontrolled hypertension
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 |
|---|---|---|
| AducanumabAs described in the treatment arm | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboIV administration of 0.9% sodium chloride | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Incidence and nature of adverse events (AE) / serious adverse events(SAE)
Time frame: Up to week 42
Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations
Time frame: Up to week 42
Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)
Time frame: Up to week 42
8 secondary outcomes
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)
Time frame: Up to 8 weeks post dosing
AUC from time zero to time of the last measurable concentration (AUC0-last)
Time frame: Up to 8 weeks post dosing
Maximum observed concentration (Cmax)
Time frame: Up to 8 weeks post dosing
Time to Cmax (Tmax)
Time frame: Up to 8 weeks post dosing
Elimination half-life (t1/2)
Time frame: Up to 8 weeks post dosing
Volume of distribution at steady state (Vss)
Time frame: Up to 8 weeks post dosing
Clearance (CL) after a single IV infusion of aducanumab
Time frame: Up to 8 weeks post dosing
Incidence of anti-aducanumab antibodies in serum
Time frame: Up to week 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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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.
Medical Director study director
Biogen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aducanumab in people with Alzheimer's Disease, run by Biogen at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and nature of adverse events (AE) / serious adverse events(SAE) (time frame: Up to week 42). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2020.