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

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ClinicalTrials.gov Identifier: NCT00422981
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : October 24, 2012
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment, So Stated Drug: AL-108 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Active Comparator: AL-108 5 mg
5 mg QD
Drug: AL-108
5 mg QD

Active Comparator: AL-108 15 mg
15 mg BID
Drug: AL-108
15 mg BID

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline to Week 12 on the Composite Memory Variable [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16 [ Time Frame: 16 weeks ]
  2. Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16). [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422981

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Sponsors and Collaborators
Allon Therapeutics
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Principal Investigator: Donald E Schmechel, MD Memory Assessment and Research Services
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allon Therapeutics
ClinicalTrials.gov Identifier: NCT00422981    
Other Study ID Numbers: AL-108-211
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012
Keywords provided by Allon Therapeutics:
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders