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To evaluate the safety, tolerability, multiple dose plasma pharmacokinetics (PK) of LNK-754 in male and female elderly volunteers after dosing with LNK-754 for 7 days and in subjects with mild Alzheimer's Disease after dosing with LNK-754 for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Dose | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNK-754 | Drug | Escalating dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments to include pharmacokinetics, and adverse events | 24 hours |
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Inclusion Criteria:
Part A and Part B:
Males or females aged 60 years or older. Females must be surgically sterilized or postmenopausal for at least two years. Males must be actively practicing double-barrier contraception (condom plus spermicide), unless they have had a vasectomy, or their partner(s) meet the above criteria for females.
Voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
Be prepared to adhere to the protocol requirements and be willing and able to remain in the study unit for the entire duration of the confinement period. They must also be willing to return for the End-of-Study Visit one week after the last dosing.
Part A only:
Subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinical deviations from normal limits in medical history, physical examination, vital sign measurements, ECG, or laboratory test results that are associated with stable, well controlled chronic illness. Subjects with concomitant diseases or using concomitant medication will be allowed to participate provided a stable condition and stable treatment for 1 month (30 days) prior to administration of the first dose of study medication. Inclusion of each subject will be reviewed with the Link Medical Monitor prior to enrollment in the trial.
Part B only:
Subjects with Mild Alzheimer's Disease, as defined by DSM-IV.
Subjects with a score of ≥ 18-26 on the Mini-Mental State Examination (MMSE).
Subjects with a Clinical Dementia Rating (CDR) total score of 0.5 or 1.0 (possible or mild dementia).
Subjects with a Rosen-Modified Hachinski Ischemic score of ≤ 4.
Exclusion Criteria:
Part A and Part B:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Riesenberg, MD | Atlanta Center for Medical Research | Principal Investigator |
| Abel Murillo, MD | Elite Research Institute | Principal Investigator |
| Craig T. Curtis, MD | Compass Research | Principal Investigator |
| Kyle Patrick, D.O. | Dedicated Phase I | Principal Investigator |
| Maxwell Axler, MD | Clinical Trial Network | Principal Investigator |
| Ricky S. Mofsen, D.O. | St. Louis Clinical Trials, LC | Principal Investigator |
| Armen Goenjian, MD | Collaborative Neuroscience Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dedicated Phase I | Phoenix | Arizona | 85013 | United States | ||
| Collaborative Neuroscience Network |
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| Drug |
Escalating dose |
|
| Long Beach |
| California |
| 90806 |
| United States |
| Elite Research Insitute | Miami | Florida | 33169 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| St. Louis Clinical Trials, LC | St Louis | Missouri | 63118 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| ID | Term |
|---|---|
| C000723819 | LNK-754 |
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