Clinical trial · Interventional
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (HOPE Study)
A Randomized, Double-blind, Sham-controlled Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (HOPE Study)
NCT05637801CI-TRIAL-00110382HOPEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (35)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease | — | UNRESOLVED | — |
| Alzheimer Disease 1 | — | UNRESOLVED | — |
| Alzheimer Disease 10 | — | UNRESOLVED | — |
| Alzheimer Disease 11 | — | UNRESOLVED | — |
| Alzheimer Disease 12 | — | UNRESOLVED | — |
| Alzheimer Disease 13 | — | UNRESOLVED | — |
| Alzheimer Disease 14 | — | UNRESOLVED | — |
| Alzheimer Disease 15 | — | UNRESOLVED | — |
| Alzheimer Disease 16 | — | UNRESOLVED | — |
| Alzheimer Disease 17 | — | UNRESOLVED | — |
| Alzheimer Disease 18 | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spectris™ AD - Active | Device | — | UNRESOLVED |
| Spectris™ AD - Sham | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active
- description
- Active Group: Subjects are treated with the Active Spectris™ AD at home for 60 minutes daily for approximately 12 months.
- interventionNames
- Device: Spectris™ AD - Active
- type
- SHAM_COMPARATOR
- label
- Sham
- description
- Sham Group: Subjects are treated with a Sham Spectris™ AD at home for 60 minutes daily for approximately 12 months
- interventionNames
- Device: Spectris™ AD - Sham
Primary outcomes (1)
- measure
- Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc), 2. neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc), 3. serious infection of the brain (meningitis/encephalitis), or 4. 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/
References
Publications (0)
Data not yet available
No reference posted for this study.