Alzheimer's DiseasePhase 1PRIMENCT01677572

Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease

A Phase 1 study testing Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in people with Alzheimer's Disease, run by Biogen at 32 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 50 to 90 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 197 participants
Where: 32 sitesUnited States
Study dates: 5 Oct 2012to 31 Jul 2019
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 50 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must be ambulatory.
Participants must meet the following core clinical criteria as determined by the Investigator:
Prodromal Alzheimer's Disease (AD) (all of the criteria must apply):
Mini Mental State Examination (MMSE) scores between 24-30 (inclusive)
a spontaneous memory complaint
objective memory loss defined as a free recall score of ≤27 on the Free and Cued Selective Reminding Test (FCSRT)

Show all 17Show fewer

a global Clinical Dementia Rating Scale (CDR) score of 0.5
absence of significant levels of impairment in other cognitive domains
essentially preserved activities of daily living, and an absence of dementia. OR
Mild Alzheimer's Disease (AD) criteria (all criteria must apply):
Mini Mental State Examination (MMSE) scores between 20-26 (inclusive)
a global Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0
meeting the National Institute on Aging-Alzheimer's Association core clinical criteria for probable AD.
Participants must have a positive florbetapir positron emission tomography (PET) amyloid scan.
Participants must consent to apolipoprotein E (ApoE) genotyping.
Apart from clinical diagnosis of Alzheimer's Disease (AD), participant must be in good health.
Must have a reliable informant or caregiver.

Who cannot join

Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.
Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year.
Clinically significant psychiatric illness in past 6 months.
Seizure in the past 3 years.
Poorly controlled diabetes mellitus.
History of unstable angina, myocardial infarction, chronic heart failure, or clinical significant conduction abnormalities within 1 year prior to Screening.

Show all 17Show fewer

Indication of impaired renal or liver function.
Have human immunodeficiency virus (HIV) infection.
Have a significant systematic illness or infection in past 30 days.
Brain MRI showing evidence of acute or sub-acute micro or macrohemorrhage, greater than 4 microhemorrhages, cortical infarct or greater than one 1 lunar infarct.
Any contraindications to brain MRI or positron emission tomography (PET) scans.
Negative positron emission tomography (PET) scan with any amyloid-targeting ligand within 48 weeks of Screening.
Clinically significant 12-lead electrocardiogram (ECG) abnormalities.
Alcohol or substance abuse in past 1 year.
Taking blood thinners (except for aspirin at a prophylactic dose or less)
Have changes in medications or doses of medication in past 4 weeks.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

Insight Clinical Trials LLC
Beachwood, Ohio, 44122
Neurostudies.net, LLC
Decatur, Georgia, 30033
Brain Matters Research, Inc.
Delray Beach, Florida, 33445
Brown Hospital
East Providence, Rhode Island, 02906
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, 60007
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
MD Clinical Trials, Inc.
Hallandale, Florida, 33009
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653
Empire Neurology, PC
Latham, New York, 12110
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
University of California, Los Angeles
Los Angeles, California, 90095
CRI Lifetree
Marlton, New Jersey, 08053
Miami Jewish Health Systems
Miami, Florida, 33137
Galiz Research, LLC
Miami Springs, Florida, 33166
Alzheimer's Disease Research Unit, Yale University
New Haven, Connecticut, 06520
Compass Research, LLC
Orlando, Florida, 32806
Pacific Neuroscience Medical Group
Oxnard, California, 93030
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
Rhode Island Hospital
Providence, Rhode Island, 02903
Pacific Research Network, Inc.
San Diego, California, 92103
San Francisco Clinical Research Center
San Francisco, California, 94109
St. Louis Clinical Trials, LLC
St Louis, Missouri, 63118
Stanford University Medical Center
Stanford, California, 94304
Infinity Clinical Research, Inc.
Sunrise, Florida, 33351
Axiom Clinical Research of Florida
Tampa, Florida, 33609
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755
NNS Clinical Research, LLC
Tucson, Arizona, 85704
Georgetown University Hospital
Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose serum concentrations of Aducanumab and to evaluate the immunogenicity of Aducanumab after multiple dose administration in this population.

Read the detailed description

The study consists of a placebo-controlled period to study week 54, followed by a long-term extension to study week 518. The placebo-controlled period is conducted with a staggered, parallel group design, with the first 3 treatment arms conducted in parallel, 2 further treatment arms subsequently beginning in parallel, 2 additional treatment arms beginning in parallel, and the last 2 treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period for up to 42 additional doses of active drug for the first 3 years of LTE. Furthermore, up until the last participant in Arms 8 and 9 has had his or her last dose in the fifth year of the LTE, eligible participants will be able to continue treatment beyond the third year of the LTE.

Conditions: Alzheimer's Disease
Being tested: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb), Placebo
Keywords: Aducanumab, BIIB037
Medical subject headings: Alzheimer Disease

What participants receive

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

Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)Drug
Also called IgG1, anti-A* mAb, Fully human
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study is conducted with a staggered, parallel group design, with the first 3 treatment arms conducted in parallel, 2 further treatment arms subsequently beginning in parallel and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
PlaceboDrug
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.

Study groups in NCT01677572
Study group	Role	What they receive
Low-dose #1 Aducanumab	Experimental	Intravenous doses of low-dose level #1 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Low-dose #2 Aducanumab	Experimental	Intravenous doses of low-dose level #2 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Placebo (low dose group)	Placebo comparator	Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb); Drug: Placebo
Mid-dose Aducanumab	Experimental	Intravenous doses of mid-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Placebo (mid dose group)	Placebo comparator	Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb); Drug: Placebo
High-dose Aducanumab	Experimental	Intravenous doses of high-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Placebo (high dose group)	Placebo comparator	Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb); Drug: Placebo
Aducanumab Titration	Experimental	Intravenous doses of Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Placebo (Titration Group)	Placebo comparator	Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses. Receives: Drug: Placebo

What is being measured

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

Number of Participants with Adverse Events
Measured: Baseline to week 518

Secondary outcomes (3)

Change from baseline in florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging in certain brain areas.
Measured: Day 1, Weeks 26, 54, End of year 2, 3, and 4
Multiple dose pharmacokinetic (PK) serum concentrations of Aducanumab
Measured: Up to week 518
Change from Baseline in Incidence of Anti-Aducanumab Antibodies in Serum.
Measured: Up to week 518

Timeline

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

5 Oct 201231 Jul 2019

First posted3 Sep 2012 (estimated)
Study start5 Oct 2012
Primary completion31 Jul 2019
Study completion31 Jul 2019

Why it stopped: Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01677572
Sponsor's protocol ID: 221AD103
Other IDs: 2012-000349-10
Acronym: PRIME
Status last verified: Jul 2020
First submitted: 30 Aug 2012
Last updated: 3 Aug 2020
Results posted: No
Data monitoring committee: Yes

Publications

Chen T, O'Gorman J, Castrillo-Viguera C, Rajagovindan R, Curiale GG, Tian Y, Patel D, von Rosenstiel P, von Hehn C, Salloway S, Hock C, Nitsch RM, Haeberlein SB, Sandrock A, Singhal P. Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab. Alzheimers Dement. 2024 May;20(5):3406-3415. doi: 10.1002/alz.13755. Epub 2024 Apr 3.
PubMed 38567735
Sevigny J, Chiao P, Bussiere T, Weinreb PH, Williams L, Maier M, Dunstan R, Salloway S, Chen T, Ling Y, O'Gorman J, Qian F, Arastu M, Li M, Chollate S, Brennan MS, Quintero-Monzon O, Scannevin RH, Arnold HM, Engber T, Rhodes K, Ferrero J, Hang Y, Mikulskis A, Grimm J, Hock C, Nitsch RM, Sandrock A. The antibody aducanumab reduces Abeta plaques in Alzheimer's disease. Nature. 2016 Sep 1;537(7618):50-6. doi: 10.1038/nature19323.
PubMed 27582220

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 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease
ClinicalTrials.gov ID: NCT01677572
Acronym / sponsor ID: PRIME / 221AD103
Conditions: Alzheimer's Disease
Keywords: Aducanumab, BIIB037
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns.
Enrolment: 197 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: 5 Oct 2012 (actual)
Primary completion: 31 Jul 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 3 Sep 2012 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 9

Arm	Type	Receives
Low-dose #1 Aducanumab	Experimental	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)Intravenous doses of low-dose level #1 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Low-dose #2 Aducanumab	Experimental	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)Intravenous doses of low-dose level #2 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Placebo (low dose group)	Placebo comparator	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb), Drug: PlaceboIntravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.
Mid-dose Aducanumab	Experimental	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)Intravenous doses of mid-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Placebo (mid dose group)	Placebo comparator	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb), Drug: PlaceboIntravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
High-dose Aducanumab	Experimental	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)Intravenous doses of high-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Placebo (high dose group)	Placebo comparator	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb), Drug: PlaceboIntravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab Titration	Experimental	Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)Intravenous doses of Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.
Placebo (Titration Group)	Placebo comparator	Drug: PlaceboIntravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.

Who may qualify

Ages: 50 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Participants must be ambulatory.
Participants must meet the following core clinical criteria as determined by the Investigator:
Mini Mental State Examination (MMSE) scores between 24-30 (inclusive)
a spontaneous memory complaint
objective memory loss defined as a free recall score of ≤27 on the Free and Cued Selective Reminding Test (FCSRT)

Key exclusion criteria (17 listed)

Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.
Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year.
Clinically significant psychiatric illness in past 6 months.
Seizure in the past 3 years.
Poorly controlled diabetes mellitus.

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
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)Also: IgG1, anti-A* mAb, Fully humanParticipants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study is conducted with a staggered, parallel group design, with the first 3 treatment arms conducted in parallel, 2 further treatment arms subsequently beginning in parallel and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.	Drug	Aducanumab Titration, High-dose Aducanumab, Low-dose #1 Aducanumab, Low-dose #2 Aducanumab, Mid-dose Aducanumab, Placebo (high dose group), Placebo (low dose group), Placebo (mid dose group)
PlaceboPlacebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.	Drug	Placebo (Titration Group), Placebo (high dose group), Placebo (low dose group), Placebo (mid dose group)

Primary outcome

Number of Participants with Adverse Events
Time frame: Baseline to week 518

3 secondary outcomes

Change from baseline in florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging in certain brain areas.
Time frame: Day 1, Weeks 26, 54, End of year 2, 3, and 4
Multiple dose pharmacokinetic (PK) serum concentrations of Aducanumab
Time frame: Up to week 518
Change from Baseline in Incidence of Anti-Aducanumab Antibodies in Serum.
Time frame: Up to week 518

Results and safety

The study was stopped early (reason given: Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
Derived from this study: PubMed 38567735Chen T, O'Gorman J, Castrillo-Viguera C, Rajagovindan R, Curiale GG, Tian Y, Patel D, von Rosenstiel P, von Hehn C, Salloway S, Hock C, Nitsch RM, Haeberlein SB, Sandrock A, Singhal P. Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab. Alzheimers Dement. 2024 May;20(5):3406-3415. doi: 10.1002/alz.13755. Epub 2024 Apr 3.
Derived from this study: PubMed 27582220Sevigny J, Chiao P, Bussiere T, Weinreb PH, Williams L, Maier M, Dunstan R, Salloway S, Chen T, Ling Y, O'Gorman J, Qian F, Arastu M, Li M, Chollate S, Brennan MS, Quintero-Monzon O, Scannevin RH, Arnold HM, Engber T, Rhodes K, Ferrero J, Hang Y, Mikulskis A, Grimm J, Hock C, Nitsch RM, Sandrock A. The antibody aducanumab reduces Abeta plaques in Alzheimer's disease. Nature. 2016 Sep 1;537(7618):50-6. doi: 10.1038/nature19323.

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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

32 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 (recombinant, fully human anti-Aβ IgG1 mAb) in people with Alzheimer's Disease, run by Biogen at 32 sites in United States.

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 17 inclusion and 17 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: stopped early, as of the sponsor's last update on 3 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 32 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?

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?

Number of Participants with Adverse Events (time frame: Baseline to week 518). 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 NCT01677572, which also lists 2 linked publications.

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 Aug 2020.