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Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to Screening and remain on their stable dose throughout the trial. Subjects will receive placebo or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid biomarkers and cognitive and psychological measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2609 | Experimental |
| |
| Placebo for E2609 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2609 | Drug | E2609 capsules: 5 mg, 25 mg, 50 mg, and 200 mg E2609 doses: 5 mg, 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, and 400 mg According to the randomized study design, participants who are assigned to receive E2609 will each receive a single assigned dose consisting of two capsules of E2609 or in some cases one capsule of E2609 and one of placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in cerebrospinal fluid amyloid-beta levels | baseline to 36 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 8 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hakop Gevorkyan | California Clinical Trials Medical Group Inc. | Principal Investigator |
| Olukemi Olugemo, MD | PAREXEL International - EPCU Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | United States | ||||
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| Placebo for E2609 | Drug | Placebo capsules According to the randomized study design, participants who are assigned to receive placebo will each receive a single dose consisting of two capsules of placebo |
|
| Baltimore |
| Maryland |
| United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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