Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-108 5 mg | Active Comparator | 5 mg QD |
|
| AL-108 15 mg | Active Comparator | 15 mg BID |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-108 | Drug | 5 mg QD |
| |
| AL-108 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 12 on the Composite Memory Variable | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald E Schmechel, MD | Memory Assessment and Research Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Research | Peoria | Arizona | 85381 | United States | ||
| Collaborative Neuroscience Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39358355 | Derived | 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. | |
| 23594991 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
15 mg BID |
|
| Placebo | Drug | Placebo |
|
| 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 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C425904 | davunetide |
Not provided
Not provided
Not provided