Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment
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ClinicalTrials.gov Identifier: NCT00422981 |
Recruitment Status :
Completed
First Posted : January 17, 2007
Last Update Posted : October 24, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | January 16, 2007 | |||
First Posted Date ICMJE | January 17, 2007 | |||
Last Update Posted Date | October 24, 2012 | |||
Study Start Date ICMJE | January 2007 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change from baseline to Week 12 on the Composite Memory Variable [ Time Frame: 12 weeks ] | |||
Original Primary Outcome Measures ICMJE |
The primary outcome measure is the change from baseline (Day 1) to Week 12 on the Composite Memory Variable | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment | |||
Official Title ICMJE | A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effect on Cognitive Function of AL-108 After 12 Weeks of Intranasal Administration in Subjects With Mild Cognitive Impairment | |||
Brief Summary | The purpose of this study is to find out if different doses of Investigational Drug are safe, tolerable, and if they have an effect on Mild Cognitive Impairment (MCI). | |||
Detailed Description | Pre-Clinical experiments indicate the AL-108 compound has neuroprotective, cognitive protective and neurotrophic properties; therefore, the compound could be tested in a variety of human diseases. Human diseases include Cognitive impairment associated with aging or neurodegenerative diseases such as Alzheimer's Disease. This clinical trial aims at providing the dose rationale as well as safety and tolerability information for AL-108 as evaluated after 12 weeks of intranasal administration in subjects with Mild Cognitive Impairment (MCI). There are currently no drugs approved for the treatment of MCI nor accepted treatment or standard treatment approach. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Mild Cognitive Impairment, So Stated | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Morimoto BH, Schmechel D, Hirman J, Blackwell A, Keith J, Gold M; AL-108-211 Study. A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment. Dement Geriatr Cogn Disord. 2013;35(5-6):325-36. doi: 10.1159/000348347. Epub 2013 Apr 13. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
144 | |||
Original Enrollment ICMJE |
120 | |||
Actual Study Completion Date ICMJE | January 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 55 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00422981 | |||
Other Study ID Numbers ICMJE | AL-108-211 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Allon Therapeutics | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Allon Therapeutics | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Allon Therapeutics | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |