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

Allon Therapeutics16 sites in 1 country144 target enrollmentJanuary 2007

ConditionsMild Cognitive Impairment, So Stated

InterventionsAL-108 Placebo

DrugsAL-108 Placebo

Overview

Phase: Phase 2
Intervention: AL-108
Conditions: Mild Cognitive Impairment, So Stated
Sponsor: Allon Therapeutics
Enrollment: 144
Locations: 16
Primary Endpoint: Change from baseline to Week 12 on the Composite Memory Variable
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

January 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allon Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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 ≤
•Mini-Mental State Exam (MMSE) ≥
•Center for Epidemiologic Studies-Depression (CES-D) score \<
•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.

Arms & Interventions

AL-108 5 mg

5 mg QD

Intervention: AL-108

AL-108 15 mg

15 mg BID

Intervention: AL-108

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline to Week 12 on the Composite Memory Variable

Time Frame: 12 weeks

Secondary Outcomes

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)