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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment, So Stated

In brief

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).

Key facts

Study ID

NCT00422981

Run by

Allon Therapeutics

People needed

144

Starts

2007-01-01

Expected to finish

2008-01-01

Last updated by the study team

2012-10-24

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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