Back to resultsATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease (LIFT-AD)
Primary Purpose
Alzheimer Disease, Dementia of Alzheimer Type
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATH-1017
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Cognition, Dementia, ATH-1017, LIFT AD, Fosgonimeton
Eligibility Criteria
Key Inclusion Criteria:
- Age 55 to 85 years
- Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
- Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
- Reliable and capable support person/caregiver
Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:
- Treatment-naïve, OR
- Subjects are on a stable, approved dose of an AChEI (except for donepezil at 23 mg PO) for at least 3 months before Screening OR
- Subjects who received an AChEI in the past and discontinued 4 weeks prior to Screening
Key Exclusion Criteria:
- History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
- Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
- History of brain MRI scan indicative of any other significant abnormality
- Diagnosis of severe major depressive disorder even without psychotic features.
- Significant suicide risk
- History within 2 years of Screening, or current diagnosis of psychosis
- Myocardial infarction or unstable angina within the last 6 months
- Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
- Subject has either hypertension or symptomatic hypotension
- Clinically significant ECG abnormality at Screening
- Renal insufficiency (serum creatinine > 2.0 mg/dL)
- Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C
- Malignant tumor within 3 years before Screening
- Memantine in any form, combination or dosage within 4 weeks prior to Screening
- Donepezil at 23 mg PO
- The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening
Sites / Locations
- University of Alabama at Birmingham
- Xenoscience
- Banner Sun Health Research Institute
- ATP Clinical Research, IncRecruiting
- Wr - Pri, LlcRecruiting
- Neurology Center of North Orange County
- Sun Valley Research Center, Inc.Recruiting
- Irvine Clinical ResearchRecruiting
- Sunwise Clinical ResearchRecruiting
- Healthy Brain Research IncRecruiting
- PRI Research
- PRI ResearchRecruiting
- Viking ClinicalRecruiting
- Denver Neurological Research, LLC
- Mile High Research CenterRecruiting
- CenExel RMCR
- JEM Research InstituteRecruiting
- Boynton Beach Medical Research Institute
- K2 Medical Research Winter GardenRecruiting
- Accel Clinical Research
- Brain Matters Research
- Neuropsychiatric Research Center of SW Florida
- Reliable Clinical Research LLCRecruiting
- K2 Medical Research-The VillagesRecruiting
- Wr-Msra, Llc
- ClinCloudRecruiting
- Merritt Island Medical ResearchRecruiting
- Global Medical Institutes, LLC dba South Miami Medical Institute
- Optimus U Corp
- Quantix ResearchRecruiting
- Innova PharmaRecruiting
- K2 Medical Research MaitlandRecruiting
- Accel Clinical ResearchRecruiting
- Progressive Medical Research
- Accel Clinical ResearchRecruiting
- Mart Medical Group ResearchRecruiting
- Premiere Research InstituteRecruiting
- Accel Clinical ResearchRecruiting
- CenExel iResearch, LLCRecruiting
- CenExelRecruiting
- Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's ResearchRecruiting
- Rush Alzheimer's Disease Center, Rush University Medical Center
- SIU Medicine Neuroscience Institute (NSI)
- Indiana University School of Medicine, Department of Neurology
- Ochsner Clinical FoundationRecruiting
- Northern Light Acadia Hospital
- PharmaSite ResearchRecruiting
- Massachusetts General Hospital
- Activmed Practices & Research, Inc.
- Boston Center for Memory
- Adams ClinicalRecruiting
- Clinical Research Professionals
- Cleveland Clinic Lou Ruvo Center for Brain Health
- M3 Wake ResearchRecruiting
- Hackensack Meridian Hackensack University Medical CenterRecruiting
- Global Medical Institutes LLC; Princeton Medical InstituteRecruiting
- Advanced Memory Research Institute of NJ
- Albuquerque Neuroscience Inc.
- Neurological Associates of AlbanyRecruiting
- Integrative Clinical Trials, LLC
- Berman ClinicalRecruiting
- Manhattan Behavioral Medicine, LLC
- University of Rochester-AD-CARE ProgramRecruiting
- ERG Clinical Research - New York, PLLC
- Atrium Health Department of PsychiatryRecruiting
- Duke Neurology ResearchRecruiting
- AMC Research, LLC
- Wake Research of RaleighRecruiting
- Insight Clinical Trials, LLCRecruiting
- Neurology DiagnosticsRecruiting
- Neurobehavioral Clinical Research
- Summit Research Network Inc.Recruiting
- Center for Cognitive HealthRecruiting
- Keystone Clinical StudiesRecruiting
- Rhode Island Mood & Memory Research Institute
- WR-ClinSearch, LLCRecruiting
- Neurology Clinical, P.C.
- Clinical Neuroscience Solutions, Inc.
- Austin Clinical Trials Partners
- Senior Adults Specialty ResearchRecruiting
- Kerwin Memory Center
- EI FARO Health and TherapeuticsRecruiting
- Grayline Research Center
- Next Stage Clinical ResearchRecruiting
- Pantheon ClinicalRecruiting
- University of Utah, Department of Neurology-Alzheimer's Disease Research
- Northwest Clinical Research CenterRecruiting
- Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchRecruiting
- Swedish Neuroscience Research
- Northwest Neurological
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dosage
Placebo
Arm Description
Daily subcutaneous (SC) injection of 40mg ATH-1017
Daily subcutaneous (SC) injection of Placebo
Outcomes
Primary Outcome Measures
To evaluate the clinical efficacy of ATH1017 in subjects not on background acetylcholinesterase inhibitors (AChEIs)
The Global Statistical Test (GST) score that combines the change from baseline scores from cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]) and function (Alzheimer's Disease Cooperative Study-Activities of Daily Living, 23-item version [ADCS-ADL23] score)
Secondary Outcome Measures
Cognition
Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11] (Range of 0 to 70, where 0 is least impairment and 70 is most severe impairment)
Activities of Daily Living
Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version [ADCS-ADL23] (Range of 0 to 78, where a higher score indicates greater function)
To determine the effect of ATH1017 on plasma neurofilament light chain (NfL) concentration
NfL concentration change from Baseline at Week 26
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04488419
Brief Title
ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Acronym
LIFT-AD
Official Title
A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Mild to Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athira Pharma
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 study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.
Detailed Description
The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia of Alzheimer Type
Keywords
Alzheimer's Disease, Cognition, Dementia, ATH-1017, LIFT AD, Fosgonimeton
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, parallel-group study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
558 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dosage
Arm Type
Experimental
Arm Description
Daily subcutaneous (SC) injection of 40mg ATH-1017
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily subcutaneous (SC) injection of Placebo
Intervention Type
Drug
Intervention Name(s)
ATH-1017
Intervention Description
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
Primary Outcome Measure Information:
Title
To evaluate the clinical efficacy of ATH1017 in subjects not on background acetylcholinesterase inhibitors (AChEIs)
Description
The Global Statistical Test (GST) score that combines the change from baseline scores from cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]) and function (Alzheimer's Disease Cooperative Study-Activities of Daily Living, 23-item version [ADCS-ADL23] score)
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Cognition
Description
Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11] (Range of 0 to 70, where 0 is least impairment and 70 is most severe impairment)
Time Frame
Week 26
Title
Activities of Daily Living
Description
Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version [ADCS-ADL23] (Range of 0 to 78, where a higher score indicates greater function)
Time Frame
Week 26
Title
To determine the effect of ATH1017 on plasma neurofilament light chain (NfL) concentration
Description
NfL concentration change from Baseline at Week 26
Time Frame
Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Age 55 to 85 years
Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
Reliable and capable support person/caregiver
Treatment-free (subjects not receiving acetylcholinesterase inhibitor [AChEI] treatment), defined as:
Treatment-naïve, OR
Subjects who received an AChEI in the past and discontinued at least 4 weeks prior to Screening
Key Exclusion Criteria:
History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
History of brain MRI scan indicative of any other significant abnormality
Diagnosis of severe major depressive disorder even without psychotic features.
Significant suicide risk
History within 2 years of Screening, or current diagnosis of psychosis
Myocardial infarction or unstable angina within the last 6 months
Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
Subject has either hypertension or symptomatic hypotension
Clinically significant ECG abnormality at Screening
Chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 mL/min
Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C
Malignant tumor within 3 years before Screening
Memantine in any form, combination or dosage within 4 weeks prior to Screening
Acetylcholinesterase inhibitors in any dosage form
The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Moebius, MD, PhD
Phone
425-620-8501
Email
clinicaltrials@athira.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Terminated
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Active, not recruiting
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
Gustavo Alva, MD
Facility Name
Wr - Pri, Llc
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grosz, MD
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sun Valley Research Center, Inc.
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardo Ng, MD
Facility Name
Irvine Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Zamrini, MD
Facility Name
Sunwise Clinical Research
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Glick, MD
Facility Name
Healthy Brain Research Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dung Trinh, MD
Facility Name
PRI Research
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
PRI Research
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Don DeFrancisco, MD
Facility Name
Viking Clinical
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Alvarez, MD
Facility Name
Denver Neurological Research, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Terminated
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
Jack Klapper, MD
Facility Name
CenExel RMCR
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Active, not recruiting
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
Mark Goldstein, MD
Facility Name
Boynton Beach Medical Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
K2 Medical Research Winter Garden
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
Nicholas Weber, DO
Facility Name
Accel Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Neuropsychiatric Research Center of SW Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Reliable Clinical Research LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilberto Cruz, MD
Facility Name
K2 Medical Research-The Villages
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Curtis, MD
Facility Name
Wr-Msra, Llc
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
ClinCloud
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esteban Olivera, MD
Facility Name
Merritt Island Medical Research
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Kirk, MD
Facility Name
Global Medical Institutes, LLC dba South Miami Medical Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Optimus U Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Quantix Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Jaramillo, MD, FAASM
Facility Name
Innova Pharma
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giralt Yanez, MD
Facility Name
K2 Medical Research Maitland
City
Orlando
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Lenox, DO
Facility Name
Accel Clinical 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
Timothy Wierzbicki, MD
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Accel Clinical Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Burke, MD
Facility Name
Mart Medical Group Research
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonzalo Quesada, MD
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Winner, MD
Facility Name
Accel Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marshall Nash, MD
Facility Name
CenExel iResearch, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimball Johnson, MD
Facility Name
CenExel
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mobley, MD
Facility Name
Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kore Liow, MD
Facility Name
Rush Alzheimer's Disease Center, Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SIU Medicine Neuroscience Institute (NSI)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Indiana University School of Medicine, Department of Neurology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ochsner Clinical Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Rini, MD
Facility Name
Northern Light Acadia Hospital
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
PharmaSite Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dima Hnoosh, MD
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Activmed Practices & Research, Inc.
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01852
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
Active, not recruiting
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Rutrick, MD
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
M3 Wake Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Farrow, MD
Facility Name
Hackensack Meridian Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manisha Parulekar, MD
Facility Name
Global Medical Institutes LLC; Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Varma, MD
Facility Name
Advanced Memory Research Institute of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Albuquerque Neuroscience Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Active, not recruiting
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
Richard Holub, MD
Facility Name
Integrative Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Berman Clinical
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Rapp, MD
Facility Name
Manhattan Behavioral Medicine, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Rochester-AD-CARE Program
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Porsteinsson, MD
Facility Name
ERG Clinical Research - New York, PLLC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Terminated
Facility Name
Atrium Health Department of Psychiatry
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oleg Tcheremissine, MD
Facility Name
Duke Neurology Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Burke, MD, PhD
Facility Name
AMC Research, LLC
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wake Research of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Marriott, MD
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
Mark Stillman, MD
Facility Name
Neurology Diagnostics
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Vandersluis, MD
Facility Name
Neurobehavioral Clinical Research
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Losk, PhD
Facility Name
Center for Cognitive Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mega, MD
Facility Name
Keystone Clinical Studies
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherian Verghese, MD
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Bear, MD
Facility Name
Neurology Clinical, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Terminated
Facility Name
Austin Clinical Trials Partners
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
98757
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaron Winston, MD
Facility Name
Kerwin Memory Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Terminated
Facility Name
EI FARO Health and Therapeutics
City
Rio Grande City
State/Province
Texas
ZIP/Postal Code
78582
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAMES A FALCON
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Next Stage Clinical Research
City
Woodway
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy Gardell, MD
Facility Name
Pantheon Clinical
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Rhudy, MD
Facility Name
University of Utah, Department of Neurology-Alzheimer's Disease Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Terminated
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arifulla Khan, MD
Facility Name
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAMES KNUTSON, MD
Facility Name
Swedish Neuroscience Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Terminated
Facility Name
Northwest Neurological
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
21514250
Citation
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
Results Reference
background
Learn more about this trial
ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
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