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Trial record 5 of 5 for:    davunetide

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allon Therapeutics
ClinicalTrials.gov Identifier:
NCT00422981
First received: January 16, 2007
Last updated: October 18, 2012
Last verified: October 2012

January 16, 2007
October 18, 2012
January 2007
January 2008   (final data collection date for primary outcome measure)
Change from baseline to Week 12 on the Composite Memory Variable [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The primary outcome measure is the change from baseline (Day 1) to Week 12 on the Composite Memory Variable
Complete list of historical versions of study NCT00422981 on ClinicalTrials.gov Archive Site
  • Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • 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).
Not Provided
Not Provided
 
Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mild Cognitive Impairment, So Stated
  • Drug: AL-108
    5 mg QD
  • Drug: AL-108
    15 mg BID
  • Drug: Placebo
    Placebo
  • 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
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.
 
Completed
144
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
55 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422981
AL-108-211
No
Allon Therapeutics
Allon Therapeutics
Not Provided
Principal Investigator: Donald E Schmechel, MD Memory Assessment and Research Services
Allon Therapeutics
October 2012

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