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Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)
This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 45 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-07-29
Primary completion: 2025-12-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06427668
Intervention or treatment
DRUG: SPG302
DRUG: Placebo
Conditions
- • Alzheimer Disease
Find a site
Closest Location:
St Vincent's Hospital
Research sites nearby
Select from list below to view details:
St Vincent's Hospital
Sydney, New South Wales, Australia
Flinders Medical center
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Part A: Active SPG302 to be administered to adult participants with AD
| DRUG: SPG302
|
PLACEBO_COMPARATOR: Part A: Placebo comparator to be administered to adult participants with AD
| DRUG: Placebo
|
EXPERIMENTAL: Part B: Expansion Cohort
| DRUG: SPG302
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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. | 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 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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) | 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 |
Frequently Asked Questions
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