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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
Sponsor:
Information provided by (Responsible Party):
Allon Therapeutics

Tracking Information
First Submitted Date  ICMJE January 16, 2007
First Posted Date  ICMJE January 17, 2007
Last Update Posted Date October 24, 2012
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Change from baseline to Week 12 on the Composite Memory Variable [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2007)
The primary outcome measure is the change from baseline (Day 1) to Week 12 on the Composite Memory Variable
Change History Complete list of historical versions of study NCT00422981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
  • Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16 [ Time Frame: 16 weeks ]
  • Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16). [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2007)
  • Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16
  • Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mild Cognitive Impairment, So Stated
Intervention  ICMJE
  • Drug: AL-108
    5 mg QD
  • Drug: AL-108
    15 mg BID
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: AL-108 5 mg
    5 mg QD
    Intervention: Drug: AL-108
  • Active Comparator: AL-108 15 mg
    15 mg BID
    Intervention: Drug: AL-108
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Morimoto BH, Schmechel D, Hirman J, Blackwell A, Keith J, Gold M; AL-108-211 Study. A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment. Dement Geriatr Cogn Disord. 2013;35(5-6):325-36. doi: 10.1159/000348347. Epub 2013 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2012)
144
Original Enrollment  ICMJE
 (submitted: January 16, 2007)
120
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00422981
Other Study ID Numbers  ICMJE AL-108-211
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allon Therapeutics
Study Sponsor  ICMJE Allon Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Donald E Schmechel, MD Memory Assessment and Research Services
PRS Account Allon Therapeutics
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP