Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000349-10 | EudraCT Number |
Not provided
Not provided
Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Baseline to week 518 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging in certain brain areas. | Day 1, Weeks 26, 54, End of year 2, 3, and 4 | |
| Multiple dose pharmacokinetic (PK) serum concentrations of Aducanumab |
Not provided
Key Inclusion Criteria:
Prodromal Alzheimer's Disease (AD) (all of the criteria must apply):
Mild Alzheimer's Disease (AD) criteria (all criteria must apply):
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NNS Clinical Research, LLC | Tucson | Arizona | 85704 | United States | ||
| Senior Clinical Trials, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38567735 | Derived | 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. | |
| 27582220 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
|
|
| Placebo | Drug | 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. |
|
| Up to week 518 |
| Change from Baseline in Incidence of Anti-Aducanumab Antibodies in Serum. | Up to week 518 |
| Laguna Hills |
| California |
| 92653 |
| United States |
| Torrance Clinical Research Institute, Inc. | Lomita | California | 90717 | United States |
| Collaborative Neuroscience Network, LLC | Long Beach | California | 90806 | United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| Pacific Neuroscience Medical Group | Oxnard | California | 93030 | United States |
| Pacific Research Network, Inc. | San Diego | California | 92103 | United States |
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States |
| Stanford University Medical Center | Stanford | California | 94304 | United States |
| Alzheimer's Disease Research Unit, Yale University | New Haven | Connecticut | 06520 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20057 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | United States |
| MD Clinical Trials, Inc. | Hallandale | Florida | 33009 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Galiz Research, LLC | Miami Springs | Florida | 33166 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Infinity Clinical Research, Inc. | Sunrise | Florida | 33351 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| Neurostudies.net, LLC | Decatur | Georgia | 30033 | United States |
| Alexian Brothers Neurosciences Institute | Elk Grove Village | Illinois | 60007 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| St. Louis Clinical Trials, LLC | St Louis | Missouri | 63118 | United States |
| Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | 07724 | United States |
| CRI Lifetree | Marlton | New Jersey | 08053 | United States |
| Advanced Memory Research Institute of NJ | Toms River | New Jersey | 08755 | United States |
| Empire Neurology, PC | Latham | New York | 12110 | United States |
| Insight Clinical Trials LLC | Beachwood | Ohio | 44122 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Brown Hospital | East Providence | Rhode Island | 02906 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| 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. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000600266 | aducanumab |
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided