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
  Purpose

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 Intervention Phase
Mild Cognitive Impairment, So Stated
Drug: AL-108
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Allon Therapeutics:

Primary Outcome Measures:
  • Change from baseline to Week 12 on the Composite Memory Variable [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 144
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 ≤ 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422981

Locations
United States, Arizona
Pivotal Research
Peoria, Arizona, United States, 85381
United States, California
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
Synergy Research
National City, California, United States, 91950
Pacific Research Network, Inc
San Diego, California, United States, 92103
United States, Florida
Meridien Research
Brooksville, Florida, United States, 34613
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Clinical Neuroscience Solutions
Orlando, Florida, United States, 32806
Meridien Research
Tampa, Florida, United States, 33606
Stedman Clinical Trials
Tampa, Florida, United States, 33613
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida, United States, 32960
United States, Illinois
Comprehensive Neuroscience
Hoffman Estates, Illinois, United States, 60194
United States, New Jersey
The Memory Enhancement Center of America
Long Branch, New Jersey, United States, 07740
United States, New York
SPRI Clinical trials
Brooklyn, New York, United States, 11235
United States, North Carolina
Memory Assessment and Research Services
Wilmington, North Carolina, United States, 28405
United States, Ohio
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Tennessee
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States, 38119
United States, Texas
Senior Adults Speciality Research
Austin, Texas, United States, 78757
Sponsors and Collaborators
Allon Therapeutics
Investigators
Principal Investigator: Donald E Schmechel, MD Memory Assessment and Research Services
  More Information

No publications provided by Allon Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allon Therapeutics
ClinicalTrials.gov Identifier: NCT00422981     History of Changes
Other Study ID Numbers: AL-108-211
Study First Received: January 16, 2007
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Allon Therapeutics:
Dementia
Memory
Alzheimers
Cognition
Mind
Aging

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014