1 |
NCT01766336 |
Terminated Has Results |
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease |
|
- Drug: Group 1 ELND005
- Drug: Group 2 ELND005
|
Interventional |
Phase 2 |
- Transition Therapeutics Ireland Limited
- Elan Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants Experiencing Treatment Emergent Adverse Events
|
296 |
All |
50 Years to 95 Years (Adult, Senior) |
NCT01766336 |
ELND005-AG251 2012-005524-15 |
|
January 2013 |
August 2015 |
August 2015 |
January 11, 2013 |
June 22, 2016 |
May 13, 2016 |
- TransitionTIL Investigational Site
Birmingham, Alabama, United States - TransitionTIL Investigational Site
Phoenix, Arizona, United States - TransitionTIL Investigational Site
Phoenix, Arizona, United States - (and 43 more...)
|
2 |
NCT00934050 |
Completed Has Results |
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease |
|
- Drug: ELND005 (scyllo-inositol)
|
Interventional |
Phase 2 |
- Transition Therapeutics Ireland Limited
- Transition Therapeutics
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment Emergent Adverse Events (TEAEs)
|
103 |
All |
Child, Adult, Senior |
NCT00934050 |
ELND005-AD251 |
|
June 2009 |
June 2011 |
June 2011 |
July 8, 2009 |
May 13, 2015 |
May 13, 2015 |
- Banner Alzheimer's Institute
Phoenix, Arizona, United States - Sun Health Research Institute
Sun City, Arizona, United States - University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, United States - (and 35 more...)
|
3 |
NCT01735630 |
Completed Has Results |
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease |
|
- Drug: ELND005
- Drug: Placebo
|
Interventional |
Phase 2 |
- Transition Therapeutics Ireland Limited
- Elan Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
- Change From Baseline in Modified-ADCS-CGIC Agitation Scores
- Change From Baseline in NPI Total Scores
- (and 2 more...)
|
350 |
All |
50 Years to 95 Years (Adult, Senior) |
NCT01735630 |
ELND005-AG201 2012-004299-20 |
|
November 2012 |
May 2015 |
May 2015 |
November 28, 2012 |
August 15, 2016 |
August 15, 2016 |
- TransitionTIL Investigational Site
Birmingham, Alabama, United States - TransitionTIL Investigational Site
Phoenix, Arizona, United States - TransitionTIL Investigational Site
Phoenix, Arizona, United States - (and 67 more...)
|
4 |
NCT01791725 |
Completed Has Results |
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia |
|
- Drug: ELND005
- Drug: Placebo
|
Interventional |
Phase 2 |
- Transition Therapeutics Ireland Limited
- Elan Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Incidence of Adverse Events (TEAEs)
|
23 |
All |
18 Years to 45 Years (Adult) |
NCT01791725 |
ELND005-DS201 |
DS201 |
September 2013 |
June 2014 |
June 2014 |
February 15, 2013 |
January 29, 2016 |
January 29, 2016 |
- University of California, San Diego
La Jolla, California, United States - University of California, Irvine
Orange, California, United States - Massachusetts General Hospital
Boston, Massachusetts, United States
|
5 |
NCT01674010 |
Terminated Has Results |
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder |
|
- Drug: ELND005
- Drug: Lamotrigine
- Drug: Valproic acid
- Drug: Placebo
|
Interventional |
Phase 2 |
- Transition Therapeutics Ireland Limited
- Elan Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Treatment Emergent Adverse Events
- Proportion of Study Participants With Recurrence of Any Mood Episode
- Time to Recurrence of a Depressive Episode
- Time to Recurrence of a Manic/Hypomanic or a Mixed Episode
|
309 |
All |
18 Years to 65 Years (Adult) |
NCT01674010 |
ELND005-BPD201 2012-001935-30 |
|
August 2012 |
June 2014 |
June 2014 |
August 28, 2012 |
May 18, 2016 |
October 12, 2015 |
- Elan Investigational Site
Birmingham, Alabama, United States - Elan Investigational Site
Glendale, Arizona, United States - Elan Investigational Site
Pheonix, Arizona, United States - (and 79 more...)
|
6 |
NCT00568776 |
Completed Has Results |
ELND005 in Patients With Mild to Moderate Alzheimer's Disease |
|
- Drug: Placebo Control
- Drug: ELND005
|
Interventional |
Phase 2 |
- Transition Therapeutics Ireland Limited
- Transition Therapeutics
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)
- Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)
- Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)
- (and 4 more...)
|
353 |
All |
50 Years to 85 Years (Adult, Senior) |
NCT00568776 |
ELND005-AD201 |
|
December 2007 |
May 2010 |
May 2010 |
December 6, 2007 |
May 16, 2016 |
March 29, 2012 |
- Banner Alzheimer's Institute
Phoenix, Arizona, United States - Sun Health Research Institute
Sun City, Arizona, United States - University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, United States - (and 59 more...)
|