Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment
NCT ID: NCT00422981
Last Updated: 2012-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2007-01-31
2008-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AL-108 5 mg
5 mg QD
AL-108
5 mg QD
AL-108 15 mg
15 mg BID
AL-108
15 mg BID
Placebo
Placebo
Placebo
Placebo
Interventions
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AL-108
5 mg QD
AL-108
15 mg BID
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Self-reported memory complaint, corroborated by spouse or companion as appropriate.
* Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5.
* Mini-Mental State Exam (MMSE) ≥24.
* Center for Epidemiologic Studies-Depression (CES-D) score \<27.
* Normal thyroid function, defined as TSH, T3 and T4 within normal limits.
* Agree not to consume alcoholic beverages within 8 hours of each study visit.
* Willing and able to sign informed consent and complete the CTB and all other tests and procedures as listed in the protocol.
* Fluently reads and speaks English.
* Female subjects must be surgically sterile or post-menopausal for at least 2 years. If \<2 years post-menopausal, then a follicle stimulating hormone (FSH) ≥40 mIU/mL must be obtained.
Exclusion Criteria
* History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
* History of alcohol or substance abuse or dependence within the past year.
* Acute infective sinusitis.
* History or presence of an abnormality of the external or internal structures of the nose or nasopharynx, except for surgical correction of the nasal septum or a "broken nose" at least 2 years previously, or surgical repair of cleft palate when \<30 years of age.
* Use of medications that are known to cause frank obtundation of cognition
* Use of any approved or investigational medication for Alzheimer's Disease within 3 months of screening
* History of or current significant systemic disease judged to interfere with the study evaluations or likely to be a safety concern.
* Untreated sleep apnea or treatment for sleep apnea for \<3 months.
* Abnormal clinical laboratory test results, specifically: Alanine transaminase (ALT) or aspartate transaminase (AST) \>2 х the upper limit of normal (ULN),Hematology \<80% the lower limit of normal, Creatinine ≥2 mg/dL and ,Other clinical laboratory values or vital signs considered clinically significant in the opinion of the Investigator.
* Treatment with any investigational drug, biologic, or device within the previous 30 days prior to screening.
* Surgery involving general anesthesia within the past 3 months or planned surgery requiring general anesthesia during the study period.
55 Years
85 Years
ALL
Yes
Sponsors
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Allon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Donald E Schmechel, MD
Role: PRINCIPAL_INVESTIGATOR
Memory Assessment and Research Services
Locations
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Pivotal Research
Peoria, Arizona, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
Synergy Research
National City, California, United States
Pacific Research Network, Inc
San Diego, California, United States
Meridien Research
Brooksville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Meridien Research
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida, United States
Comprehensive Neuroscience
Hoffman Estates, Illinois, United States
The Memory Enhancement Center of America
Long Branch, New Jersey, United States
SPRI Clinical trials
Brooklyn, New York, United States
Memory Assessment and Research Services
Wilmington, North Carolina, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Senior Adults Speciality Research
Austin, Texas, United States
Countries
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References
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Gozes I, Blatt J, Lobyntseva A. Davunetide sex-dependently boosts memory in prodromal Alzheimer's disease. Transl Psychiatry. 2024 Oct 2;14(1):412. doi: 10.1038/s41398-024-03118-0.
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.
Other Identifiers
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AL-108-211
Identifier Type: -
Identifier Source: org_study_id