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patients treated on compassionate use program
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This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALZ-101 with mild to moderate Alzheimer's Disease (AD)
This is an open-label extension study of SPG302-ALZ-101 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with mild-to-moderate AD. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Extension | Experimental | Active SPG302 to be administered to adult participants with AD who completed initial study. Dose to be administered to be dose received during previous study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPG302 | Drug | small synthetic molecule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events and serious adverse events | Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 52 weeks |
| 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 evaluates the level of actual or potential medical damage. The range is 0-25.Min is 0 and Max is 25. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. The range is 0-30. Min is 0 and Max is 30. | up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Any physical or psychological condition that prohibits study completion
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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 |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Open Label extension
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| Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint |
The 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. Min is 0 and Max is 70. The higher the score the greater the impairment. |
| up to 52 weeks |
| Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint | The 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. Per question scored at 1-2-3-4. Overall range is Min is 13 and Max is 52. | up to 52 weeks |
| Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint | The 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. Range is 1-7. Min 1 and Max is 7. | up to 52 weeks |
| Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint | The CDR-SB is an interview performed with patient and caregiver, and will stage the severity of cognitive impairment. The higher the score, the greater the impairment. Range is 0-18. Min is 0 and Max is 18. | up to 52 weeks |
| Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint. | The ADCS-ADL is a metric to assess the ability to perform basic and instrumental activities of daily living. It is completed by a caregiver as a questionnaire or interview questions, and evaluates activities within the previous four weeks. Changes in symptom severity are indicated on a seven-point scale. A lower scale indicates greater impairment. Each question is 0-3. Total score is 78. Min is 0 and Max is 78. | up to 52 weeks |
| Change in serum neurofilament light chain (NfL) 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 | up to 52 weeks |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |