Alzheimer Disease
Conditions
Keywords
Alzheimer Disease, synapse, neural connectivity, Dementia
Brief summary
This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.
Detailed description
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
Interventions
DRUGSPG302
synthetic small molecule
DRUGPlacebo
Placebo
Sponsors
Spinogenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Double blinded
Intervention model description
Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 45-85 * Diagnosis of mild to moderate AD * Clinical laboratory values within normal range or \< 1.5 times ULN * If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug. * Life expectancy of \>2 years * Able and willing to provide written informed consent
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 |
|---|---|---|
| Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint | 8 months | 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. |
| C-SSRS (Columbia Suicide Severity Rating Scale) | 8 months | 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. |
| Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint | 8 months | 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. |
| Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint | 8 months | 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. |
| Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint | 8 months | 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. |
| Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint | 8 months | 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. |
| Change in Mini-Mental State Examination (MMSE) from baseline to endpoint | 8 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax) | 8 months | Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration. |
| Change in biomarkers in participants with AD from baseline to endpoint. | 8 months | To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter. |
| Safety and tolerability of SPG302 | 8 months | Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs) |
Countries
Australia
Outcome results
None listed