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A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011) (Hope)

Primary Purpose

Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Sham
Sponsored by
Cognito Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Mild Cognitive Impairment, Dementia

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) in the 6 months prior to consent or during study 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 For more information visit: https://www.hopestudyforad.com/

Sites / Locations

  • CCT Research - Gilbert Neurology PartnersRecruiting
  • Barrow Neurological InstituteRecruiting
  • CCT Research - Foothills Research CenterRecruiting
  • Banner Sun Health Research InstituteRecruiting
  • Advanced Research Center, IncRecruiting
  • ATP Clinical Research, Inc.Recruiting
  • Neurology Center of North Orange CountyRecruiting
  • Syrentis Clinical ResearchRecruiting
  • Office of Elizabeth Zarate-Rowell, MDRecruiting
  • Mile High Research CenterRecruiting
  • JEM Research InstituteRecruiting
  • South Lake Pain InstituteRecruiting
  • Arrow Clinical TrialsRecruiting
  • Brain Matters ResearchRecruiting
  • Neuropsychiatric Research Center of Southwest FloridaRecruiting
  • Alphab Global Research
  • Charter Research - Lady LakeRecruiting
  • Multi-Specialty Research Associates, Inc.Recruiting
  • Premier Clinical Research Institute Inc.
  • Coastal Family Medicine - Orange ParkRecruiting
  • Emerald Coast NeurologyRecruiting
  • Quantum LaboratoriesRecruiting
  • Progressive Medical ResearchRecruiting
  • Suncoast Neuroscience AssociatesRecruiting
  • Intercoastal Medical Group - SarasotaRecruiting
  • Brain Matters ResearchRecruiting
  • Conquest ResearchRecruiting
  • Charter Research - Winter ParkRecruiting
  • Emory Alzheimer's Disease Research Center
  • NeuroStudiesRecruiting
  • Great Lakes Clinical Trials- Flourish Research- ChicagoRecruiting
  • Great Lakes Clinical Trials- Flourish Research- GurneeRecruiting
  • Josephson Wallack Munshower Neurology, PC
  • Northern Light Acadia HospitalRecruiting
  • Boston Clinical Trials, Inc.
  • Boston Center for MemoryRecruiting
  • Office of Donald S. Marks, M.D., P.C.Recruiting
  • Sisu BHR, LLCRecruiting
  • QUEST Research InstituteRecruiting
  • Hattiesburg ClinicRecruiting
  • CCT Research - Papillion Research CenterRecruiting
  • Las Vegas Medical ResearchRecruiting
  • The Cognitive and Research Center of New JerseyRecruiting
  • Neurological Associates of AlbanyRecruiting
  • Integrative Clinical Trials, LLC
  • Velocity Clinical Research - SyracuseRecruiting
  • Mid Hudson Medical ResearchRecruiting
  • Alzheimer's Memory Center - AMC ResearchRecruiting
  • Insight Clinical Trials, LLCRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • The Clinical Trial CenterRecruiting
  • Prisma Health NeurologyRecruiting
  • Coastal NeurologyRecruiting
  • University of Tennessee Medical Center
  • North Texas Clinical TrialsRecruiting
  • UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative DiseasesRecruiting
  • TRS HealthRecruiting
  • Mercury Clinical ResearchRecruiting
  • Wasatch Clinical ResearchRecruiting
  • ReCogniton Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active

Control

Arm Description

Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.

Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.

Outcomes

Primary Outcome Measures

Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
Function as measured by the ADCS-ADL
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
Function and Cognition as measured by CST for ADCS-ADL and MMSE

Secondary Outcome Measures

Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months
Cognition as measured by MMSE
Change from Baseline in Whole brain volume at 12-Months
Whole brain volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Change from Baseline in Hippocampal volume at 12-Months
Hippocampal volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months
Global change in symptoms as measured by CDR

Full Information

First Posted
November 22, 2022
Last Updated
October 13, 2023
Sponsor
Cognito Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05637801
Brief Title
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
Acronym
Hope
Official Title
A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cognito Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Approximately 530 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).
Detailed Description
This is a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression versus Sham for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE). Secondary objectives will include measures of cognition and neuroanatomical change. Five-hundred and thirty (530) Mild to Moderate Alzheimer's disease subjects (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Treatment: Control). In the Treatment Group, subjects will be treated with the Active Sensory Stimulation System once daily. In the Control Group, subjects are treated with a Sham Sensory Stimulation System once daily. Daily treatment is planned for up to 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 2, Alzheimer Disease 3, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer Disease 9, Alzheimer Disease 4, Alzheimer Disease 7, Alzheimer Disease 17, Alzheimer's Dementia Late Onset, Alzheimer Disease 5, Alzheimer Disease 6, Alzheimer Disease 8, Alzheimer Disease 10, Alzheimer Disease 11, Alzheimer Disease 12, Alzheimer Disease 13, Alzheimer Disease 14, Alzheimer Disease 15, Alzheimer Disease 16, Alzheimer Disease 18, Alzheimer Disease 19, Dementia, Dementia Alzheimers, Dementia, Mild, Dementia of Alzheimer Type, Dementia Moderate, Dementia Senile, Mild Cognitive Impairment, Mild Dementia, MCI, Cognitive Impairment, Cognitive Decline, Cognitive Impairment, Mild
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects with Alzheimer's Disease
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.
Intervention Type
Device
Intervention Name(s)
Sensory Stimulation System (GS120) - Active
Intervention Description
Sensory Stimulation System (GS120) - Active settings
Intervention Type
Device
Intervention Name(s)
Sensory Stimulation System (GS120) - Sham
Intervention Description
Sensory Stimulation System (GS120) - Sham settings
Primary Outcome Measure Information:
Title
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
Description
Function as measured by the ADCS-ADL
Time Frame
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Title
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
Description
Function and Cognition as measured by CST for ADCS-ADL and MMSE
Time Frame
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Outcome Measure Information:
Title
Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months
Description
Cognition as measured by MMSE
Time Frame
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Title
Change from Baseline in Whole brain volume at 12-Months
Description
Whole brain volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Time Frame
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Title
Change from Baseline in Hippocampal volume at 12-Months
Description
Hippocampal volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)
Time Frame
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Title
Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months
Description
Global change in symptoms as measured by CDR
Time Frame
Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) in the 6 months prior to consent or during study 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 For more information visit: https://www.hopestudyforad.com/
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Galley
Phone
(857) 201-5088
Email
agalley@cognitotx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Hempel
Phone
(857) 201-5088
Email
ehempel@cognitotx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Kern, MD
Organizational Affiliation
Cognito Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCT Research - Gilbert Neurology Partners
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Padilla
Phone
480-653-8212
Email
jessicapadilla@cctresearch.com
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margeaux Snell
Phone
800-392-2222
Email
margeaux.snell@dignityhealth.org
Facility Name
CCT Research - Foothills Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Wall
Phone
602-883-8405
Email
andrewwall@cctresearch.com
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Liebsack
Phone
623-832-6514
Email
carolyn.liebsack@bannerhealth.com
Facility Name
Advanced Research Center, Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Hye Yi
Phone
714-999-6688
Email
dr.yi@arctrials.com
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobby Shih
Phone
714-277-4472
Email
bshih@atpcr.com
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheraz Mossa
Phone
714-879-7200
Email
smossa@neurologyoc.com
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorrie Bisesi
Phone
714-542-3008
Email
lbisesi@syrentis.com
Facility Name
Office of Elizabeth Zarate-Rowell, MD
City
Seal Beach
State/Province
California
ZIP/Postal Code
90740
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Gupta
Phone
562-548-8500
Email
ngupta@allianceforresearch.com
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicki Sudan
Phone
303-839-9900
Email
vicki.sudan@yahoo.com
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Torres
Phone
561-968-2933
Email
jtorres@jemri.net
Facility Name
South Lake Pain Institute
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Colon
Phone
352-394-0833
Email
jcolon@slpain.com
Facility Name
Arrow Clinical Trials
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishnu Nitta
Phone
386-278-8000
Email
vnitta@arrowtrials.com
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jetliza Lesmes
Phone
561-374-8461
Ext
1100
Email
jlesmes@ergclinical.com
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Perez
Phone
239-208-6269
Email
eperez@ergclinical.com
Facility Name
Alphab Global Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Individual Site Status
Terminated
Facility Name
Charter Research - Lady Lake
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Ortiz
Phone
352-268-7200
Email
brittany.ortiz@charterresearch.com
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
23055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Lowrey
Phone
386-438-8977
Ext
114
Email
regulatory@msrainc.com
Facility Name
Premier Clinical Research Institute Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Terminated
Facility Name
Coastal Family Medicine - Orange Park
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janette Groth
Phone
904-468-3125
Ext
4118
Email
jgroth@ccrsjax.com
Facility Name
Emerald Coast Neurology
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Briggs
Phone
850-273-4929
Email
sharon.briggs@synergyclinicalresearch.net
Facility Name
Quantum Laboratories
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose De La Gandara
Phone
954-933-2324
Email
Quantumres2@quantum-lab.com
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantelle Funge
Phone
386-304-7070
Email
Chantellef@progressivemedicalresearch.com
Facility Name
Suncoast Neuroscience Associates
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Klein
Phone
727-202-2623
Email
jklein@suncoastneuroresearch.com
Facility Name
Intercoastal Medical Group - Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanette Wilson
Phone
941-866-0321
Email
jewilson@intercoastalmedical.com
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jetliza Lesmes
Phone
561-374-8461
Ext
1100
Email
jlesmes@ergclinical.com
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa O'Neill
Phone
407-848-3845
Email
melissa.oneill@conquestresearch.com
Facility Name
Charter Research - Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Blair
Phone
407-337-1000
Email
Tina.Blair@charterresearch.com
Facility Name
Emory Alzheimer's Disease Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabria Saleh
Phone
404-712-2123
Email
sabria.saleh@emory.edu
Facility Name
NeuroStudies
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Scantlin
Phone
404-475-0552
Email
jscantlin@accelclinical.com
Facility Name
Great Lakes Clinical Trials- Flourish Research- Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Rzecznik
Phone
773-275-3500
Email
wrzecznik@flourishresearch.com
Facility Name
Great Lakes Clinical Trials- Flourish Research- Gurnee
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Gustavsen
Phone
847-915-6044
Email
lgustavsen@flourishresearch.com
Facility Name
Josephson Wallack Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northern Light Acadia Hospital
City
Bangor
State/Province
Maine
ZIP/Postal Code
04402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Weidman
Phone
207-973-7726
Email
jweidman@northernlight.org
Facility Name
Boston Clinical Trials, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Jasinski
Phone
617-699-6927
Email
rachel@bostonmemory.com
Facility Name
Office of Donald S. Marks, M.D., P.C.
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Moore
Phone
508-746-5060
Email
clarem@dsmmdpc.com
Facility Name
Sisu BHR, LLC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Perreault
Phone
800-289-6539
Email
bperreault@sisuhealth.com
Facility Name
QUEST Research Institute
City
Farmington
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Scholtz
Phone
248-957-8940
Email
christine.scholtz@alcanzaclinical.com
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayleigh Russell
Phone
601-579-5016
Email
kayleigh.russell@hattiesburgclinic.com
Facility Name
CCT Research - Papillion Research Center
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Puente
Phone
402-979-8770
Email
johnpuente@cctresearch.com
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bharat Mocherla
Phone
702-750-0222
Ext
102
Email
bobbym@lvmedresearch.com
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chelsea Nigro
Phone
973-850-4622
Email
info@theCRCNJ.com
Facility Name
Neurological Associates of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Staff
Phone
518-426-0575
Email
research@naaresearch.com
Facility Name
Integrative Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Velocity Clinical Research - Syracuse
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veolcity Clinical Research Syracuse
Phone
315-760-5905
Email
info@velocityclinical.com
Facility Name
Mid Hudson Medical Research
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
845-674-9398
Email
crc@mhmresearch.com
Facility Name
Alzheimer's Memory Center - AMC Research
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen Bolouri
Phone
704-364-4000
Ext
235
Email
ssbolouri@amcneurology.com
Facility Name
Insight Clinical Trials, LLC
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Poggi
Phone
216-526-1843
Email
epoggi@insightclinicaltrials.com
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Vrettos
Phone
614-366-8642
Email
nicole.vrettos@osumc.edu
Facility Name
The Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alketa Dobi
Phone
215-884-1700
Email
alketa@theclinicaltrialcenter.com
Facility Name
Prisma Health Neurology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvin McElveen
Phone
803-434-8050
Email
william.mcelveen@prismahealth.org
Facility Name
Coastal Neurology
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29935
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daisy White
Phone
843-522-1420
Email
daiwhi8855@gmail.com
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenda Brown
Phone
865-305-7915
Email
gbrown@utmck.edu
Facility Name
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Nelson
Phone
817-744-8844
Email
tamara.nelson@ntxct.com
Facility Name
UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Floyd Jones
Phone
210-450-3158
Email
jonesfa@uthscsa.edu
Facility Name
TRS Health
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Chunawala
Phone
713-367-2791
Email
imran@rhclinicalresearch.com
Facility Name
Mercury Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercury Clinical Research
Phone
713-777-5343
Email
info@mercurycr.us.com
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Hanks
Phone
801-288-0607
Email
ahanks@wasatchcrc.com
Facility Name
ReCogniton Health
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)

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