A Randomized, Double-blind, Sham-controlled Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (HOPE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 673
- 试验地点
- 68
- 主要终点
- Change from Baseline in Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
研究概览
简要总结
This is a randomized, double-blind, sham-controlled pivotal study of sensory stimulation in subjects with mild to moderate AD. Up to approximately 670 subjects will be treated with either Active or Sham investigational device, Spectris™ AD, for 60 minutes daily for approximately 12 months. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).
详细描述
This is a multicenter, randomized, double-blind, sham-controlled pivotal study.
The objective of this study is to assess the safety and efficacy of gamma sensory stimulation (visual and audio) via Spectris ™ AD in slowing cognitive-functional symptom worsening versus the Sham device for subjects with mild to moderate AD as measured by changes in function and cognition.
Up to approximately six hundred and seventy (670) subjects with Mild to Moderate AD (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Active : Sham). In the Active Group, subjects will be treated with the Active Spectris™ AD for 60 minutes daily. In the Sham Group, subjects are treated with a Sham Spectris™ AD for 60 minutes daily. Daily treatment is planned for approximately 12 months.
Subjects will attend study visits for informed consent, screening and baseline, then at 3-Months, 6-Months, 9-Months (by phone), 12 Months and 13 Months (for safety follow-up).
Some clinical sites will be included in a substudy evaluating additional fluid biomarkers. Select subjects enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study; the investigator, the subject and study partner, and all other study personnel involved with subject assessments will remain blinded to the actual treatment assignment of the subjects. The Sponsor and their delegates involved in the study will be blinded to actual treatment assignment with the exception of technicians who are necessarily unblinded to assign and maintain the Investigational Devices and data analysis personnel as indicated in the Statistical Analysis Plan (SAP). Technicians and customer service agents who interact with subjects, their study partners and clinical sites will be specially trained to not reveal the study assignment (Active or Sham).
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women age 50-90
- •Alzheimer's disease diagnosis with at least 6-month decline in cognitive function
- •Non-childbearing potential or using adequate birth control
- •Mini-Mental State Exam (MMSE) 15-28
- •Available/consenting Study Partner
- •Able to identify a Legally Authorized Representative (LAR)
- •Stable chronic conditions at least 30 days
- •Formal education of 8 or more years
- •Adequate vision (Able to detect light) and hearing
- •Mobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)
- •Amyloid or phosphorylated Tau positivity
排除标准
- •Seizure disorder
- •Hospitalization in previous 30 days
- •Living in continuous care nursing home (assisted living permitted)
- •Inability to have an MRI or significant abnormality on MRI screening
- •Geriatric Depression Scale (GDS) >6
- •Suicidality (current or previous 6 months)
- •Serious neurological diseases affecting the Central Nervous System, including:
- •other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
- •neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),
- •serious infection of the brain (meningitis/encephalitis), or
- •history of multiple concussions.
- •Metabolic or systemic diseases affecting the central nervous system (syphilis, B12 or folate deficiency, etc)
- •Schizophrenia or bipolar disorder
- •Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid disease
- •Cancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)
- •Nootropic drugs except stable acetylcholinesterase inhibitors
- •Drug or Alcohol abuse in previous 12 months
- •Previous exposure to Anti-amyloid-beta vaccines
- •Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
- •Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consent
- •Involved in a previous Cognito study or gamma therapy study
- •Active treatment with Memantine (Namenda or Namzaric) within previous 30 days
- •Life expectancy < 24 months
- •Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture.
- •For more information visit: https://www.hopestudyforad.com/
研究组 & 干预措施
Sham
Sham Group: Subjects are treated with a Sham Spectris™ AD at home for 60 minutes daily for approximately 12 months
干预措施: Spectris™ AD - Sham (Device)
Active
Active Group: Subjects are treated with the Active Spectris™ AD at home for 60 minutes daily for approximately 12 months.
干预措施: Spectris™ AD - Active (Device)
结局指标
主要结局
Change from Baseline in Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
时间窗: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Function and Cognition as measured by CST for ADCS-ADL and MMSE
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
时间窗: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Function as measured by the ADCS-ADL
Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS)
时间窗: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Comparing the change from baseline (CFB) to 12 months in iADMARS between active vs sham groups.
次要结局
- Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Change from Baseline in Whole brain volume at 12-Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Change from Baseline in Hippocampal volume at 12-Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Alzheimer's Disease Cooperative Study-Activities of Daily Living ADCS-ADL(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Mini-Mental State Examination (MMSE)(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Alzheimer's Disease Cooperative Study- instrumental Activities of Daily Living (ADCS-iADL)(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)