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NCT01561053 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease
A Phase 2 study of Alzheimers Disease, sponsored by Instituto Grifols, S.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 347
- Enrollment target
- 20
- Study locations
NCT01561053: Completed Phase 2 study of Alzheimers Disease, sponsored by Instituto Grifols, S.A..
NCT01561053 is a Phase 2 study of Alzheimers Disease that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 347 participants, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561053, a Phase 2 study of Alzheimers Disease, has completed, sponsored by Instituto Grifols, S.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 347 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.
Primary Outcome
ADAS-Cog total score as a change from baseline to 14 months The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitiv
Conditions Studied
Interventions
- BIOLOGICAL Albumin 5%
- BIOLOGICAL Albumin 20%
- BIOLOGICAL Immunoglobulin
Study Locations (20)
Florida
- Bradenton Research Center, Inc. - Bradenton
- Quantum Laboratories - Deerfield Beach
- Galiz Research, LLC - Hialeah
- Largo Medical Center - Largo
- L&L Research Choices, Inc - Miami
- Allied Biomedical Research Institute - Miami
- Miami Dade Medical Research Institute, LLC - Miami
- Neurology Associates of Osmond Beach - Ormond Beach
- PharmaSeek LLC (DMI Research) - Pinellas Park
Georgia
- iResearch Atlanta, LLC - Decatur
- RTR Medical Group - Savannah
New Jersey
- The NeuroCognitive Institute - Mount Arlington
- Mid-Atlantic Geriatric/ARC - Paterson
Ohio
- The Cleveland Clinic Foundation - Cleveland
- Neurology Specialists Inc - Dayton
California
- Northern California Research - Sacramento
Colorado
- Mountain View Clinical Research, Inc - Denver
District of Columbia
- Howard University - Washington D.C.
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2012-04-19 |
| Est. Completion | 2018-03-06 |
| Phase | Phase 2 |
What the finished NCT01561053 record still lists
NCT01561053 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 3 interventions - of which Albumin 5% is the first listed.
NCT01561053 names 20 study sites across 9 states, led by Florida, Georgia, New Jersey.
Frequently Asked Questions
What is clinical trial NCT01561053 about?
NCT01561053 is a clinical study titled "A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease". The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.
What is the current status of trial NCT01561053?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 347 participants. The study started on 2012-04-19. Estimated completion is 2018-03-06.
What conditions does trial NCT01561053 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01561053?
The interventions under investigation include: Albumin 5% (BIOLOGICAL), Albumin 20% (BIOLOGICAL), Immunoglobulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01561053?
This trial is sponsored by Instituto Grifols, S.A., which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01561053 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01561053's enrollment target sits among peer trials
347 40th of 147 higher than 108 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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