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GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
COR388 capsule
Placebo capsule
Sponsored by
Cortexyme Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Subject has probable AD dementia according to the NIA-AA criteria.
  • Subject has an MMSE score 12 and 24 inclusive at both screening and Visit 2 and a ≤3-point difference between these visits.
  • Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.
  • Subject has a Modified Hachinski score ≤4 at screening.
  • Subjects with background symptomatic therapy with acetylcholine esterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.
  • Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
  • Subject has body mass index <38 kg/m2 at Screening

Key Exclusion Criteria:

  • Subject has imaging consistent with a dementia diagnosis other than AD.
  • Subject has had an increase or restoration of cognition based on medical history.
  • Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient's ability to perform the study and all assessments. NOTE: Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. The use of anti-depressants or the use of anti epileptic medication for non seizure-related treatment is allowed if the dose has remained stable for at least 60 days prior to enrollment.

  • Subject has any of the following laboratory findings at screening:

    1. Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate aminotransferase >3 x ULN, or history of clinically significant liver disease in the Investigator's judgment.
    2. Hemoglobin ≤10 g/dl.
    3. Creatinine clearance (CL) of <45 ml/min.
    4. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >8.
    5. Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.

Sites / Locations

  • Xenoscience, Inc.
  • Banner Alzheimer's Institute
  • Banner Sun Health
  • ATP Clinical Research, Inc.
  • Alliance Research
  • Standford University
  • CITRIALS
  • CITRIALS
  • Syrentis Clinical Research
  • Southern California Research LLC
  • JEM Research Institute
  • Brain Matters Research
  • Neuropsychiatric Research Center of Southwest Florida
  • MD Clinical
  • Indago Research and Health Center, Inc.
  • Alzheimer's Research and Treatment Center
  • Qtrials, Inc.
  • Future Care Solutions, LLC
  • Miami Dade Medical Research Institute
  • Sensible Healthcare LLC
  • Bioclinica Research
  • Anchor Neuroscience
  • Suncoast Neuroscience Associates, Inc.
  • Brain Matters Research at the Kane Center
  • Stedman Clinical Trials
  • Columus Memory Center
  • NeuroStudies.net, LLC
  • Northwest Clinical Trials
  • Alexian Brothers Neurosciences Research
  • Ascension Via Christi Research
  • Activmed Practices and Research
  • The Boston Center for Memory
  • Anil Nair MD, Alzheimer's Disease Center
  • Memory Center
  • Cleveland Clinic Lou Ruvo Center for Brain Health
  • Princeton Medical Institute
  • The Cognitive Research Center of New Jersey
  • Neurology Specialists of Monmouth County
  • Albuquerque Neuroscience
  • Disease Research & Neurology Center of Neurological Associates of Albany
  • Integrative Clinical Trials LLC
  • Spri Clinicaltrials, Llc
  • Mid Hudson Medical Research
  • ANI Neurology, PLLC dba Alzheimer's Memory Center
  • Insight Clinical Trials, LLC
  • Neurology Diagnostics Inc.
  • Memory Health Center at Summit Research Network
  • Northeastern Pennsylvania Memory and Alzheimer's Center
  • Senior Adults Specialty Research
  • Kerwin Research Center
  • Neurology Consultants of Dallas
  • Houston Methodist Department of Neurology
  • Clinical Trial Network
  • University of Virginia Adult Neurology
  • Recognition Health
  • Northwest Clinical Research Center
  • UW Alzheimer's Disease Research Center
  • Medical College of Wisconsin, Inc.
  • Hôpital de Brabois
  • Centre de Ressources Biologiques
  • University Hospital La Timone, Department of Neurology and Neuropsychology
  • Service de Gériatrie
  • Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre
  • CHRU de Nancy Hôpital de Brabois Service de Gériatrie
  • Brain Research Center
  • PreCare Trial & Recruitment
  • Brain Research Center Den Bosch B.V.
  • Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde
  • Brain Research Center Zwolle
  • Indywidualna Specjalistyczna Praktyka Lekarska
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
  • Krakowska Akademia Neurologii
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Euromedis Sp. z o.o.
  • Centrum Medyczne NeuroProtect
  • NZOZ Wrocławskie Centrum Alzheimerowskie
  • Policlinica Gipuzkoa
  • Hospital General de Alicante
  • Hospital de la Santa Creu i Sant Pau
  • Fundacio Ace
  • Hospital Clinic de Barcelona
  • Hospital Universitario Ramón Y Cajal
  • Hospital Universitari General de Catalunya
  • Hospital Universitario Marqués de Valdecilla
  • Cognition Health Birmingham (private)
  • St Pancras Clinical Research (private)
  • Cognition Health Plymouth
  • Memory Assessment and Research Centre, Moorgreen Hospital
  • RICE - The Research Institute for the Care of Older People
  • Glasgow Memory Clinic
  • Cognition Health Ltd. (private) Guildford
  • Cognition Health Ltd. (private) London
  • Kingshill Research Centre Swindon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

COR388 80 mg twice daily (BID)

COR388 40 mg BID

Placebo BID

Arm Description

COR388 hydrochloric acid (HCl), 80 mg orally administered capsule, BID (twice daily) with water approximately 12 hours apart and no less than 6 hours apart

COR388 HCl, 40 mg orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart

Placebo orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.

Secondary Outcome Measures

Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Mini-Mental State Examination (MMSE)
Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome
Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders. Total score ranges from 12 to 144; higher scores indicate greater disease severity.

Full Information

First Posted
January 24, 2019
Last Updated
February 22, 2023
Sponsor
Cortexyme Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03823404
Brief Title
GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
Official Title
GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.
Detailed Description
This was a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable Alzheimer's disease (AD) dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The subject did not have other conditions or brain imaging abnormalities that could explain the symptoms of dementia. All subjects were encouraged to have lumbar punctures (LPs) (during screening, week 24 and week 48) in the absence of medical conditions that could increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF), saliva, and blood were analyzed for measurements of biomarkers of AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of Porphyromonas gingivalis (P. gingivalis). A subset of sites monitored subjects for clinical evidence of periodontitis at baseline, 24 and 48 weeks. The study consisted of 3 phases: a screening phase of up to 6 weeks, a treatment phase of up to 48 weeks, and a safety follow-up phase of 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
643 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COR388 80 mg twice daily (BID)
Arm Type
Experimental
Arm Description
COR388 hydrochloric acid (HCl), 80 mg orally administered capsule, BID (twice daily) with water approximately 12 hours apart and no less than 6 hours apart
Arm Title
COR388 40 mg BID
Arm Type
Experimental
Arm Description
COR388 HCl, 40 mg orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
Placebo orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart
Intervention Type
Drug
Intervention Name(s)
COR388 capsule
Other Intervention Name(s)
atuzaginstat
Intervention Description
BID (twice daily)
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Other Intervention Name(s)
atuzaginstat
Intervention Description
BID
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
Description
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Time Frame
Baseline to Week 48
Title
Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
Description
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory. The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
Time Frame
Baseline to Week 48
Secondary Outcome Measure Information:
Title
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Description
Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Time Frame
Baseline to Week 48
Title
Mini-Mental State Examination (MMSE)
Description
Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome
Time Frame
Baseline to Week 48
Title
Neuropsychiatric Inventory (NPI)
Description
Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders. Total score ranges from 12 to 144; higher scores indicate greater disease severity.
Time Frame
Baseline to Week 48
Other Pre-specified Outcome Measures:
Title
Anti-P. Gingivalis IgG in Serum
Description
Anti-P. gingivalis immunoglobulin G (IgG) in serum Antibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU) Lower levels represent a pharmacodynamic effect of the drug on its target
Time Frame
Baseline to Week 48
Title
Magnetic Resonance Imaging
Description
Change in magnetic resonance imaging - bilateral whole brain volume Larger volume may represent effect of the drug on its target
Time Frame
Baseline to Week 48
Title
Periodontal (or Gum) Pocket Depth
Description
Periodontal (or gum) pocket depth - pocket depth for only sites with depth >= 4mm. The primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm. Larger measure means worse outcome
Time Frame
Baseline to Week 48

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Male and female.
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Subject has probable AD dementia according to the NIA-AA criteria. Subject has an Mini-Mental State Examination (MMSE) score 12 and 24 inclusive at both screening and Visit 2 and a ≤3-point difference between these visits. Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI. Subject has a Modified Hachinski score ≤4 at screening. Subjects with background symptomatic therapy with acetylcholine esterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study. Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements. Subject has body mass index <38 kg/m2 at Screening Key Exclusion Criteria: Subject has imaging consistent with a dementia diagnosis other than AD. Subject has had an increase or restoration of cognition based on medical history. Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient's ability to perform the study and all assessments. Note: Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. The use of anti-depressants or the use of anti epileptic medication for non seizure-related treatment is allowed if the dose has remained stable for at least 60 days prior to enrollment. Subject has any of the following laboratory findings at screening: Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate aminotransferase >3 x ULN, or history of clinically significant liver disease in the Investigator's judgment. Hemoglobin ≤10 g/dl. Creatinine clearance (CL) of <45 ml/min. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >8. Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Smith, MD
Organizational Affiliation
Quince Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
Xenoscience, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Banner Sun Health
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Alliance Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Standford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
CITRIALS
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
CITRIALS
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Southern California Research LLC
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Indago Research and Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Alzheimer's Research and Treatment Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Qtrials, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Future Care Solutions, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Miami Dade Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Sensible Healthcare LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Anchor Neuroscience
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Brain Matters Research at the Kane Center
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Columus Memory Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
NeuroStudies.net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Alexian Brothers Neurosciences Research
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Ascension Via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Activmed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
The Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Anil Nair MD, Alzheimer's Disease Center
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Memory Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
The Cognitive Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Neurology Specialists of Monmouth County
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Albuquerque Neuroscience
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Disease Research & Neurology Center of Neurological Associates of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Integrative Clinical Trials LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Spri Clinicaltrials, Llc
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Mid Hudson Medical Research
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
ANI Neurology, PLLC dba Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Insight Clinical Trials, LLC
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Neurology Diagnostics Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Memory Health Center at Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Northeastern Pennsylvania Memory and Alzheimer's Center
City
Plains
State/Province
Pennsylvania
ZIP/Postal Code
18507
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Kerwin Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Neurology Consultants of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Houston Methodist Department of Neurology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
University of Virginia Adult Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Recognition Health
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
UW Alzheimer's Disease Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hôpital de Brabois
City
Toulouse
State/Province
Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Centre de Ressources Biologiques
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University Hospital La Timone, Department of Neurology and Neuropsychology
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Service de Gériatrie
City
Nice
ZIP/Postal Code
6100
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHRU de Nancy Hôpital de Brabois Service de Gériatrie
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Brain Research Center
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
PreCare Trial & Recruitment
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Facility Name
Brain Research Center Den Bosch B.V.
City
Den Bosch
ZIP/Postal Code
5223 LA
Country
Netherlands
Facility Name
Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Brain Research Center Zwolle
City
Zwolle
ZIP/Postal Code
8025 AZ
Country
Netherlands
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Gdańsk
ZIP/Postal Code
80-438
Country
Poland
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Krakowska Akademia Neurologii
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
NEURO-CARE Sp. z o.o. Sp. Komandytowa
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Euromedis Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
NZOZ Wrocławskie Centrum Alzheimerowskie
City
Wrocław
ZIP/Postal Code
53-659
Country
Poland
Facility Name
Policlinica Gipuzkoa
City
San Sebastián
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8005
Country
Spain
Facility Name
Fundacio Ace
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitario Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitari General de Catalunya
City
Sant Cugat Del Vallès
ZIP/Postal Code
8195
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Cognition Health Birmingham (private)
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B16 8LT
Country
United Kingdom
Facility Name
St Pancras Clinical Research (private)
City
Barbican
State/Province
London
ZIP/Postal Code
EC2Y 8EA
Country
United Kingdom
Facility Name
Cognition Health Plymouth
City
Plymouth
State/Province
Science Park
ZIP/Postal Code
PL5 8BT
Country
United Kingdom
Facility Name
Memory Assessment and Research Centre, Moorgreen Hospital
City
Southampton
State/Province
UK
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
Facility Name
RICE - The Research Institute for the Care of Older People
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Glasgow Memory Clinic
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
Cognition Health Ltd. (private) Guildford
City
Guildford
ZIP/Postal Code
GU2 7YD
Country
United Kingdom
Facility Name
Cognition Health Ltd. (private) London
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Kingshill Research Centre Swindon
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease

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