Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease, synapse, neural connectivity
Brief summary
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)
Detailed description
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.
Interventions
DRUGSPG302
small synthetic molecule
Sponsors
Spinogenix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label extension
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild to moderate AD * Clinical laboratory values within normal range or \< 1.5 times ULN * Life expectancy of \>2 years * Able and willing to provide written informed consent * Must have participated in all study activities of SPG302-ALZ-101, the parent study
Exclusion criteria
Any physical or psychological condition that prohibits study completion * Known cardiac disease * Active or history of malignancy in the past 5 years * Serious infection that will not be resolved by first day of study intervention. * History of clinically significant CNS event or diagnosis in the past 5 years. * Acute illness within 30 days of Day 1 * History of suicidal behavior or suicidal ideation * History of chronic alcohol use or substance abuse in the last 5 years * HIV, hepatitis B and/or hepatitis C positive * Vaccines within 14 days * Receipt of investigational products within 30 days * Blood donation within 30 days * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events and serious adverse events | Up to 52 weeks | Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) |
| C-SSRS (Columbia Suicide Severity Rating Scale) | Up to 52 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint | up to 52 weeks | 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. |
| Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint | up to 52 weeks | 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. |
| Change in Mini-Mental State Examination (MMSE) from baseline to endpoint | up to 52 weeks | 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. |
| Change in Alzheimer's Disease Cooperative Study - Daily Living Inventory (ADCS-ADL) from baseline to endpoint. | up to 52 weeks | 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. |
| Change in serum neurofilament light chain (NfL) in participants with AD from baseline to endpoint. | up to 52 weeks | To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter |
| Change in Alzheimer's Disease Clinical Dementia Rating Sum of Boxes (CDR-SB) from baseline to endpoint | up to 52 weeks | 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. |
| Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint | up to 52 weeks | 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. |
Countries
Australia
Outcome results
None listed