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
1 other identifier
interventional
144
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2007
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 16, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedOctober 24, 2012
October 1, 2012
1 year
January 16, 2007
October 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to Week 12 on the Composite Memory Variable
12 weeks
Secondary Outcomes (2)
Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16
16 weeks
Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).
16 weeks
Study Arms (3)
AL-108 5 mg
ACTIVE COMPARATOR5 mg QD
AL-108 15 mg
ACTIVE COMPARATOR15 mg BID
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Pivotal Research
Peoria, Arizona, 85381, United States
Collaborative Neuroscience Network
Garden Grove, California, 92845, United States
Synergy Research
National City, California, 91950, United States
Pacific Research Network, Inc
San Diego, California, 92103, United States
Meridien Research
Brooksville, Florida, 34613, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32806, United States
Meridien Research
Tampa, Florida, 33606, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida, 32960, United States
Comprehensive Neuroscience
Hoffman Estates, Illinois, 60194, United States
The Memory Enhancement Center of America
Long Branch, New Jersey, 07740, United States
SPRI Clinical trials
Brooklyn, New York, 11235, United States
Memory Assessment and Research Services
Wilmington, North Carolina, 28405, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119, United States
Senior Adults Speciality Research
Austin, Texas, 78757, United States
Related Publications (2)
Gozes I, Blatt J, Lobyntseva A. Davunetide sex-dependently boosts memory in prodromal Alzheimer's disease. Transl Psychiatry. 2024 Oct 2;14(1):412. doi: 10.1038/s41398-024-03118-0.
PMID: 39358355DERIVEDMorimoto 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.
PMID: 23594991DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald E Schmechel, MD
Memory Assessment and Research Services
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2007
First Posted
January 17, 2007
Study Start
January 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
October 24, 2012
Record last verified: 2012-10