1 |
NCT02760602 |
Terminated Has Results |
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease |
|
- Drug: Solanezumab
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
- Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
- Change From Baseline on the Mini Mental Status Examination (MMSE)
- (and 14 more...)
|
26 |
All |
55 Years to 85 Years (Adult, Older Adult) |
NCT02760602 |
16349 H8A-MC-LZBE 2016-000108-27 |
ExpeditionPRO |
June 2016 |
May 2017 |
May 2017 |
May 3, 2016 |
July 24, 2018 |
July 24, 2018 |
- Xenoscience
Phoenix, Arizona, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - St Josephs Hospital and Medical Center
Phoenix, Arizona, United States - (and 190 more...)
|
|
2 |
NCT01900665 |
Terminated Has Results |
Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo |
|
- Drug: Solanezumab
- 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 Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)
- Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)
- Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)
- (and 15 more...)
|
2129 |
All |
55 Years to 90 Years (Adult, Older Adult) |
NCT01900665 |
15136 H8A-MC-LZAX |
EXPEDITION 3 |
July 2013 |
October 2016 |
February 2017 |
July 16, 2013 |
May 3, 2018 |
March 14, 2018 |
- Xenoscience
Phoenix, Arizona, United States - Banner Alzheimer's Institute
Phoenix, Arizona, United States - St Josephs Hospital and Medical Center
Phoenix, Arizona, United States - (and 195 more...)
|
|
3 |
NCT01127633 |
Terminated Has Results |
Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease |
|
- Drug: Solanezumab
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
- Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
- Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
- (and 10 more...)
|
1457 |
All |
55 Years and older (Adult, Older Adult) |
NCT01127633 |
11935 H8A-MC-LZAO |
EXPEDITION EXT |
December 2010 |
July 2014 |
February 2017 |
May 21, 2010 |
June 5, 2018 |
May 3, 2018 |
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sun City, Arizona, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tucson, Arizona, United States - (and 144 more...)
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4 |
NCT01148498 |
Completed |
A Biomarker Study of Solanezumab in Patients With and Without Alzheimer's |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3)
- Mean change in plasma levels of Aβ1-42 after solanezumab infusion
- Mean change in plasma levels of Aβ1-40 species after solanezumab infusion
- Mean change in plasma levels of modified Aβ species after solanezumab infusion
|
55 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01148498 |
13572 H8A-MC-LZAT |
|
August 2010 |
August 2012 |
August 2012 |
June 22, 2010 |
September 25, 2012 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St. Louis, Missouri, United States
|
|
5 |
NCT02008357 |
Active, not recruiting |
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss |
|
- Drug: Placebo
- Drug: Solanezumab
|
Interventional
|
Phase 3 |
- Eli Lilly and Company
- Alzheimer's Therapeutic Research Institute
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Baseline of the Preclinical Alzheimer Cognitive Composite (PACC)
- Change from Baseline in Cognitive Function Index (CFI)
- Change from Baseline in Alzheimer's Disease Cooperative Study—Activities Daily Living—Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score
- (and 6 more...)
|
1150 |
All |
65 Years to 85 Years (Older Adult) |
NCT02008357 |
15275 H8A-MC-LZAZ |
A4 |
February 28, 2014 |
July 22, 2022 |
July 22, 2022 |
December 11, 2013 |
December 4, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Banner Health Research Institute
Phoenix, Arizona, United States - Barrow Neurological Institute
Phoenix, Arizona, United States - (and 65 more...)
|
|
6 |
NCT00905372 |
Completed |
Effect of LY2062430 on the Progression of Alzheimer's Disease |
|
- Drug: LY2062430
- 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 to endpoint in Alzheimer's Disease Assessment Scale—Cognitive subscore (ADAS-Cog11)
- Change from baseline to endpoint in Alzheimer's Disease Cooperative Study—Activities of Daily Living Inventory (ADCS-ADL)
- Change from baseline to endpoint in Clinical Dementia Rating—Sum of Boxes (CDR-SB)
- (and 8 more...)
|
1000 |
All |
55 Years and older (Adult, Older Adult) |
NCT00905372 |
6747 H8A-MC-LZAM |
EXPEDITION |
May 2009 |
April 2012 |
April 2012 |
May 20, 2009 |
September 25, 2012 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sun City, Arizona, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tuscon, Arizona, United States - (and 82 more...)
|
|
7 |
NCT00749216 |
Completed |
Solanezumab Safety Study in Japanese Patients With Alzheimer's Disease |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events
- Changes in the extended ADAS-Cog stand for Alzheimer's Disease Assessment Scale-Cognitive subscale
- pharmacodynamic of Aβ1-40 and Aβ1-42
- Pharmacokinetics
|
33 |
All |
50 Years and older (Adult, Older Adult) |
NCT00749216 |
12025 H8A-JE-LZAK |
|
September 2008 |
July 2009 |
July 2009 |
September 9, 2008 |
June 2, 2010 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ehime, Japan - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hiroshima, Japan - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyogo, Japan - (and 3 more...)
|
|
8 |
NCT00904683 |
Completed |
Effect of LY2062430 on the Progression of Alzheimer's Disease |
|
- Drug: LY2062430
- 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 to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)
- Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
- Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score
- (and 8 more...)
|
1040 |
All |
55 Years and older (Adult, Older Adult) |
NCT00904683 |
11934 H8A-MC-LZAN |
EXPEDITION2 |
May 2009 |
June 2012 |
June 2012 |
May 20, 2009 |
December 13, 2012 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tucson, Arizona, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, United States - (and 92 more...)
|
|
9 |
NCT00329082 |
Completed |
Effects of LY2062430 in Subjects With Mild-to-Moderate Alzheimer's Disease and in Healthy Volunteers |
|
- Drug: LY2062430
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Safety and tolerability
- To determine the plasma pharmacokinetics of LY2062430
- To evaluate the pharmacokinetic/pharmacodynamic relationships between LY2062430 concentrations and plasma peptide amyloid beta concentrations
- To evaluate the changes in thinking and memory
|
25 |
All |
50 Years and older (Adult, Older Adult) |
NCT00329082 |
6649 H8A-MC-LZAJ |
|
May 2006 |
May 2008 |
May 2008 |
May 24, 2006 |
October 7, 2009 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New Haven, Connecticut, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Washington, District of Columbia, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States - (and 3 more...)
|
|
10 |
NCT02614131 |
Terminated |
A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) |
- Healthy
- Alzheimer's Disease
- Mild Cognitive Impairment
|
- Drug: LY2599666
- Drug: Solanezumab
- Drug: Placebo SC
- Drug: Placebo IV
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 and Solanezumab
- Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY2599666 and Solanezumab
- Plasma Amyloid Beta (Abeta) Concentration
|
130 |
All |
20 Years and older (Adult, Older Adult) |
NCT02614131 |
15491 I2L-MC-ALCA |
|
December 2015 |
December 2016 |
December 2016 |
November 25, 2015 |
January 10, 2017 |
|
- Parexel Early Phase Unit at Glendale
Glendale, California, United States - CRI Lifetree
Marlton,, New Jersey, United States - PRA Health Sciences
Salt Lake City, Utah, United States - (and 2 more...)
|
|
11 |
NCT01760005 |
Active, not recruiting |
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. |
- Alzheimers Disease
- Dementia
- Alzheimers Disease, Familial
|
- Drug: Gantenerumab
- Drug: Solanezumab
- Drug: Matching Placebo (Gantenerumab)
- (and 3 more...)
|
Interventional
|
Phase 2 Phase 3 |
- Washington University School of Medicine
- Eli Lilly and Company
- Hoffmann-La Roche
- (and 5 more...)
|
Other / Industry / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assess cognitive efficacy in individuals with mutations causing dominantly inherited AD as measured by change in the DIAN-TU cognitive composite score.
- Gantenerumab: Cerebral amyloid imaging using [11C]PiB-PET.
- Solanezumab: Total Abeta 1-42 (Aβ42) in CSF.
- (and 3 more...)
|
438 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT01760005 |
DIAN-TU-001 The Alzheimer's Association U01AG042791 2013-000307-17 R01AG046179 REec-2014-0817 R56AG053267 GHR Foundation |
DIAN-TU |
December 2012 |
September 2023 |
December 2023 |
January 3, 2013 |
June 6, 2018 |
|
- University of Alabama in Birmingham
Birmingham, Alabama, United States - University of California San Diego Medical Center
La Jolla, California, United States - USC Keck School of Medicine
Los Angeles, California, United States - (and 33 more...)
|
|