Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment

Phase 2

Completed

• Conditions: Mild Cognitive Impairment, So Stated
• Interventions: Drug: AL-108; Drug: Placebo

• Registration Number: NCT00422981
• Lead Sponsor: Allon Therapeutics

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-17
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Disposition First Submitted: 2012-07-11
• Status Verified: 2012-10
• Disposition First Submitted QC: 2012-10-10
• Disposition First Posted: 2012-10-12
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Is male or female, at 55-85 years of age (inclusive) at screening
• 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

• Subjects who have any significant, untreated psychiatric illness or any CNS condition (such as schizophrenia, Parkinson's disease, stroke, etc.) that could interfere with the study evaluations or procedures or which poses an additional risk. Subjects with a history of uncomplicated depression may participate if in remission and on a stable dose of antidepressant medication for at least 2 months.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-108 5 mg	AL-108	5 mg QD
AL-108 15 mg	AL-108	15 mg BID
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 12 on the Composite Memory Variable	12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16	16 weeks
Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).	16 weeks

Trial Locations

Locations (16)

Pivotal Research; 🇺🇸 Peoria, Arizona, United States

Clinical Neuroscience Solutions, Inc; 🇺🇸 Memphis, Tennessee, United States

Clinical Neuroscience Solutions; 🇺🇸 Orlando, Florida, United States

Memory Assessment and Research Services; 🇺🇸 Wilmington, North Carolina, United States

Senior Adults Speciality Research; 🇺🇸 Austin, Texas, United States

SPRI Clinical trials; 🇺🇸 Brooklyn, New York, United States

The Memory Enhancement Center of America; 🇺🇸 Long Branch, New Jersey, United States

Clinical Research Center of Indian River Medical Center; 🇺🇸 Vero Beach, Florida, United States

Synergy Research; 🇺🇸 National City, California, United States

Collaborative Neuroscience Network; 🇺🇸 Garden Grove, California, United States

Pacific Research Network, Inc; 🇺🇸 San Diego, California, United States

Meridien Research; 🇺🇸 Tampa, Florida, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Jacksonville, Florida, United States

Neurology & Neuroscience Center of Ohio; 🇺🇸 Toledo, Ohio, United States

Stedman Clinical Trials; 🇺🇸 Tampa, Florida, United States

Comprehensive Neuroscience; 🇺🇸 Hoffman Estates, Illinois, United States