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This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.
This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts:
Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles
Part B: a randomized expansion cohort of daily dosing for 28 day cycles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Active SPG302 to be administered to adult participants with AD | Active Comparator | Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be 300 mg orally once daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to cohort 2: 12 additional participants pending review of data, for additional dose exploration. |
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| Part A: Placebo comparator to be administered to adult participants with AD | Placebo Comparator | Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be placebo capsule orally daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to 12 additional participants as cohort 2 pending review of data, for additional dose exploration. |
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| Part B: Expansion Cohort | Experimental | Dose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPG302 | Drug | synthetic small molecule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint | Electroencephalogram (EEG) will provide non-invasive measurement of brain activity. This test will be used to measure resting state cognitive activity as well as cognitive activity after auditory stimulation. Sound stimuli is 500Hz and 2000Hz. | 8 months |
| Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint | The Alzheimer's Disease Assessment Scale-Cognitive Subscale test (ADAS-Cog) measures language and memory, focusing on cognitive and non-cognitive functioning. It evaluates word recall, naming of objects, word recognition, comprehension and word finding. The ADAS-COG is scored 0-70. The higher the score the greater the impairment. | 8 months |
| Change in Mini-Mental State Examination (MMSE) from baseline to endpoint | The Mini-Mental State Exam (MMSE) is a test of cognitive function. It includes tests of orientation, attention, memory, language and visual-spatial skills. The lower the score the greater the impairment. | 8 months |
| C-SSRS (Columbia Suicide Severity Rating Scale) | Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale inquires about the level of actual or potential medical damage. | 8 months |
| Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint | The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) is a metric for clinical assessment of symptom severity. It consists of 2 parts. First a baseline evaluation of patient and caregiver is performed to collect necessary clinical information. The clinician will then conduct the second phase of the assessment after a specified time period, and changes in symptom severity are indicated on a seven point scale. A higher scale indicates a worsening of symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SPG302 | Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs) | 8 months |
| Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Priest, MBBS | Flinders Medical Center, Adelaide, SA, Australia | Principal Investigator |
| Brew Brew, MBBS,MD,DSC | St Vincents Hospital, Sydney, NSW, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia | ||
| Flinders Medical center |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Double blinded
| Placebo | Drug | Placebo |
|
| 8 months |
| Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint | The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale is an scale that assesses the performance of daily tasks and activities. A lower score indicates lower functional performance. | 8 months |
| Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint | The Quality of Life in Alzheimer's Disease (QOL-AD) is a test to evaluate the quality of life through a series of questions of ability to complete daily activities and tasks. A lower score indicates lower functional quality of life. | 8 months |
Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration.
| 8 months |
| Change in biomarkers in participants with AD from baseline to endpoint. | To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter. | 8 months |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |