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NCT01864655 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of AZD0530 (Saracatinib) in Alzheimer's Disease
A Phase 1 study of Alzheimers Disease, sponsored by Stephen M. Strittmatter.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01864655: Completed Phase 1 study of Alzheimers Disease, sponsored by Stephen M. Strittmatter.
NCT01864655 is a Phase 1 study of Alzheimers Disease that has completed, run by Stephen M. Strittmatter. The registered enrollment target is 24 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01864655, a Phase 1 study of Alzheimers Disease, has completed, sponsored by Stephen M. Strittmatter.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Alzheimer's disease is a devastating neurodegenerative disorder, for which there is currently no effective treatment to slow or halt progression. Beta amyloid peptide accumulates in the brains of those with Alzheimer's, and is thought to play a major role in triggering the dementia. The investigators recently characterized a molecular pathway by which ß-amyloid damages neurons, and showed that the protein termed Fyn kinase is crucial. Our data suggest that blocking Fyn will have a significant therapeutic benefit for Alzheimer's. Astra Zeneca has developed a blocker of Fyn and related kinases (AZD0530) for the treatment of cancer. Chronic AZD0530 administration is well tolerated in humans, and the investigators propose to test its potential as a novel Alzheimer's disease modifying therapy. This study will assess the safety and tolerability of AZD0530 in patients with Alzheimer's disease.
Primary Outcome
Patients will be followed closely for any adverse events. These include laboratory measurements, such as complete blood cell counts, basic metabolic panel, including renal function and electrolyte levels, coagulations factors, and liver function tests. These measures will be assessed weekly. Patients will have cognitive testing weekly, to ensure the absence of a prominent decline in function while on study drug. General daily function will be assessed, and any clinical symptoms, such as dizzines
Conditions Studied
Interventions
- DRUG Placebo
- DRUG saracatinib
Study Locations (1)
Connecticut
- Yale Alzheimer's Disease Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-11-06 |
| Phase | Phase 1 |
What the finished NCT01864655 record still lists
NCT01864655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01864655 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01864655 about?
NCT01864655 is a clinical study titled "Safety and Tolerability of AZD0530 (Saracatinib) in Alzheimer's Disease". Alzheimer's disease is a devastating neurodegenerative disorder, for which there is currently no effective treatment to slow or halt progression. Beta amyloid peptide accumulates in the brains of those with Alzheimer's, and is thought to play a major role in triggering the dementia. The investigator...
What is the current status of trial NCT01864655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-07. Estimated completion is 2014-11-06.
What conditions does trial NCT01864655 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01864655?
The interventions under investigation include: Placebo (DRUG), saracatinib (DRUG).
Who is sponsoring clinical trial NCT01864655?
This trial is sponsored by Stephen M. Strittmatter, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01864655 being conducted?
This trial has 1 study location across Connecticut. 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 NCT01864655's enrollment target sits among peer trials
24 123rd of 147 higher than 24 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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