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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
St Vincent's Hospital
Sydney, New South Wales, Australia
Flinders Medical center
Adelaide, South Australia, Australia
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 8 months
Safety and tolerability of SPG302
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 8 months
Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)
Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration.
Time frame: 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.
Time frame: 8 months