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

Mild Cognitive Impairment, So Stated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422981
• Other study ID #: AL-108-211
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2007
• Last updated: October 18, 2012
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: October 2012
• Source: Allon Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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 ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Mild Cognitive Impairment, So Stated

Intervention

Drug:
• AL-108
5 mg QD
• AL-108
15 mg BID
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Senior Adults Speciality Research	Austin	Texas
United States	SPRI Clinical trials	Brooklyn	New York
United States	Meridien Research	Brooksville	Florida
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	Comprehensive Neuroscience	Hoffman Estates	Illinois
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	The Memory Enhancement Center of America	Long Branch	New Jersey
United States	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee
United States	Synergy Research	National City	California
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Pivotal Research	Peoria	Arizona
United States	Pacific Research Network, Inc	San Diego	California
United States	Meridien Research	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
United States	Clinical Research Center of Indian River Medical Center	Vero Beach	Florida
United States	Memory Assessment and Research Services	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Week 12 on the Composite Memory Variable		12 weeks	No
Secondary	Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16		16 weeks	No
Secondary	Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).		16 weeks	No