| 1 |
NCT03352557 |
Active, not recruiting |
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease |
|
- Drug: BIIB092
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
- Percentage of Participants With Anti-BIIB092 Antibodies in Serum Over Time up to Week 90
|
654 |
All |
50 Years to 80 Years (Adult, Older Adult) |
NCT03352557 |
251AD201 2017-002901-37 |
TANGO |
May 3, 2018 |
July 9, 2021 |
June 30, 2024 |
November 24, 2017 |
September 20, 2019 |
|
- Research Site
Birmingham, Alabama, United States - Xenoscience Inc
Phoenix, Arizona, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - (and 102 more...)
|
|
| 2 |
NCT02484547 |
Active, not recruiting |
221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease |
|
- Drug: Aducanumab (BIIB037)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in CDR-SB score
- Change from baseline in MMSE score
- Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13)
- Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL-MCI) score
|
1605 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT02484547 |
221AD302 2015-000967-15 |
EMERGE |
September 30, 2015 |
January 30, 2020 |
April 30, 2022 |
June 29, 2015 |
April 24, 2019 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - Xenoscience Inc.
Phoenix, Arizona, United States - (and 189 more...)
|
|
| 3 |
NCT02477800 |
Active, not recruiting |
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease |
|
- Drug: Aducanumab (BIIB037)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in CDR-SB score
- Change from baseline in MMSE score
- Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13)
- Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL-MCI) score
|
1605 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT02477800 |
221AD301 2015-000966-72 |
ENGAGE |
August 31, 2015 |
January 30, 2020 |
April 30, 2022 |
June 23, 2015 |
April 24, 2019 |
|
- St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States - Center for Neurosciences
Tucson, Arizona, United States - Neurology Center of North Orange County
Fullerton, California, United States - (and 178 more...)
|
|
| 4 |
NCT03056729 |
Recruiting |
Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease |
- Alzheimer's Disease
- Healthy Volunteer
|
- Drug: BIIB076
- Drug: Placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
- BIIB076 serum pharmacokinetics (PK) concentration levels
- PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)
- (and 7 more...)
|
48 |
All |
50 Years to 80 Years (Adult, Older Adult) |
NCT03056729 |
243HV101 |
|
February 17, 2017 |
February 14, 2020 |
February 14, 2020 |
February 17, 2017 |
September 6, 2019 |
|
- MD Clinical
Hallandale Beach, Florida, United States - Bioclinica Research
Orlando, Florida, United States - Progressive Medical Research
Port Orange, Florida, United States - (and 6 more...)
|
|
| 5 |
NCT03639987 |
Active, not recruiting |
A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities |
- Cognitive Dysfunction
- Alzheimer's Disease
|
- Drug: Aducanumab
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)
- Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)
- Time to Onset of ARIA as Obtained on MRI
- (and 8 more...)
|
500 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT03639987 |
221AD205 2018-002102-31 |
EVOLVE |
December 20, 2018 |
July 9, 2021 |
November 13, 2023 |
August 21, 2018 |
April 16, 2019 |
|
- Banner Alzheimer's Institute
Phoenix, Arizona, United States - Center for Neurosciences
Tucson, Arizona, United States - Neurology Center of North Orange County
Fullerton, California, United States - (and 27 more...)
|
|
| 6 |
NCT03036280 |
Active, not recruiting |
A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease_ |
|
- Drug: Elenbecestat (E2609)
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Eisai Co., Ltd.
- Biogen
- Eisai Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Core Study: Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at 24 Months
- Open-Label Extension Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs)
- Open-Label Extension Phase: Number of Participants With Abnormal Clinically Significant Vital Signs Values
- (and 16 more...)
|
950 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT03036280 |
E2609-G000-302 2016-004128-42 |
MissionAD2 |
December 29, 2016 |
November 21, 2023 |
November 21, 2023 |
January 30, 2017 |
September 19, 2019 |
|
- Facility #1
Gilbert, Arizona, United States - Facility #1
Phoenix, Arizona, United States - Facility #1
Little Rock, Arkansas, United States - (and 280 more...)
|
|
| 7 |
NCT02956486 |
Active, not recruiting |
A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease |
|
- Drug: Elenbecestat (E2609)
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Eisai Co., Ltd.
- Biogen
- Eisai Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Core Study: Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at 24 Months
- Open-Label Extension Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs)
- Open-Label Extension Phase: Number of Participants With Abnormal Clinically Significant Vital Signs Values
- (and 16 more...)
|
950 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT02956486 |
E2609-G000-301 2016-003928-23 |
MissionAD1 |
October 20, 2016 |
November 21, 2023 |
November 21, 2023 |
November 7, 2016 |
September 19, 2019 |
|
- Facility #1
Chandler, Arizona, United States - Facility #1
Colton, California, United States - Facility #1
Costa Mesa, California, United States - (and 255 more...)
|
|
| 8 |
NCT03887455 |
Recruiting |
A Study to Confirm Safety and Efficacy of BAN2401 in Participants With Early Alzheimer's Disease |
- Early Alzheimer's Disease
|
- Drug: BAN2401
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Core Study: Change from Baseline in the CDR-SB at 18 Months
- Extension Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
- Extension Phase: Change from Core Study Baseline in CDR-SB
- (and 3 more...)
|
1566 |
All |
50 Years to 90 Years (Adult, Older Adult) |
NCT03887455 |
BAN2401-G000-301 2018-004739-58 |
Clarity AD |
March 27, 2019 |
February 24, 2022 |
March 7, 2024 |
March 25, 2019 |
July 12, 2019 |
|
- Neurological Associates of Tucson dba Center for Neurosciences
Tucson, Arizona, United States - Neurology Center of North Orange County
Fullerton, California, United States - University of California - Los Angeles
Los Angeles, California, United States - (and 151 more...)
|
|
| 9 |
NCT02322021 |
Active, not recruiting |
Dose-Finding Study To Evaluate the Safety and Tolerability of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease |
- Alzheimer Disease
- Dementia, Alzheimer Type
|
- Drug: Elenbecestat (E2609)
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of treatment emergent adverse event (TEAEs) and serious adverse events (SAEs)
- Percentage change from baseline in cerebrospinal fluid (CSF) Abeta(1-x) and Abeta(1-42) after 4 weeks and 18 months of treatment in MCI/Prodromal participants and mild to moderate AD participants
- Mean plasma concentration of elenbecestat, including the effect of intrinsic and extrinsic factors [including N-acetyltransferase 2 (NAT2) phenotype]
- Mean CSF concentration of elenbecestat, including the effect of intrinsic and extrinsic factors [including N-acetyltransferase 2 (NAT2) phenotype]
|
71 |
All |
50 Years to 85 Years (Adult, Older Adult) |
NCT02322021 |
E2609-G000-202 |
|
November 26, 2014 |
March 27, 2018 |
July 31, 2022 |
December 22, 2014 |
June 10, 2019 |
|
- CITrials
Bellflower, California, United States - ATP Clinical Research
Costa Mesa, California, United States - Behavioral Research Specialists
Glendale, California, United States - (and 39 more...)
|
|
| 10 |
NCT03088956 |
Active, not recruiting |
Cognitive, Behavioral, and Functional Change in Behavioral Variant Frontotemporal Dementia (bvFTD) |
- Frontotemporal Dementia
- Behavioral Variant Frontotemporal Dementia
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall
- Annualized rate of change in Detection Test
- Annualized rate of change in Identification Test
- (and 58 more...)
|
40 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03088956 |
992FD001 |
FORWARD |
January 29, 2018 |
October 28, 2019 |
October 28, 2019 |
March 24, 2017 |
July 1, 2019 |
|
- Research Site
Birmingham, Alabama, United States - Research Site
Los Angeles, California, United States - Research Site
Boca Raton, Florida, United States - (and 10 more...)
|
|