Current partner codePEPTIDESDE
NCT00422981·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

144

Locations

17

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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).

Full 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.

Interventions

Treatment arms and agents.

DRUG

AL-108

5 mg QD

DRUG

AL-108

15 mg BID

DRUG

Placebo

Placebo

Timeline

From registration to results.

  1. First posted

    Jan 17, 2007

  2. Study start

    Jan 2007

  3. Primary completion

    Jan 2008

  4. Study completion

    Jan 2008

  5. Results posted

    Not reported

  6. Registry updated

    Oct 24, 2012

Outcomes

What the study measures.

Primary outcomes

Change from baseline to Week 12 on the Composite Memory Variable

Time frame · 12 weeks

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
55 Years
Maximum age
85 Years
Sex
ALL
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.

Study locations

17 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Pivotal Research

Peoria, Arizona, United States

Collaborative Neuroscience Network

Garden Grove, California, United States

Synergy Research

National City, California, United States

Pacific Research Network, Inc

San Diego, California, United States

Meridien Research

Brooksville, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Clinical Neuroscience Solutions

Orlando, Florida, United States

Meridien Research

Tampa, Florida, United States

Stedman Clinical Trials

Tampa, Florida, United States

Clinical Research Center of Indian River Medical Center

Vero Beach, Florida, United States

Comprehensive Neuroscience

Hoffman Estates, Illinois, United States

The Memory Enhancement Center of America

Long Branch, New Jersey, United States

SPRI Clinical trials

Brooklyn, New York, United States

Memory Assessment and Research Services

Wilmington, North Carolina, United States

Neurology & Neuroscience Center of Ohio

Toledo, Ohio, United States

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, United States

Senior Adults Speciality Research

Austin, Texas, United States

Related trials

More studies on Davunetide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.