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An Efficacy and Safety Study of Atabecestat in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia (EARLY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02569398
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimer's dementia.

Condition or disease Intervention/treatment Phase
Asymptomatic Amyloid-positive Drug: Atabecestat, 5 mg Drug: Atabecestat, 25 mg Drug: Placebo Phase 2 Phase 3

Detailed Description:
This is a randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), multi-center (more than one hospital or medical school team work on a medical research study), placebo-controlled, parallel-group study in participants who are asymptomatic and at risk for developing Alzheimer's dementia. The study will consist of a Screening Phase (approximately 90 days), treatment Phase (54 months) and follow-up Phase (7 to 28 days). In treatment Phase eligible Participants will be randomized to receive study drug or placebo once daily for up to 4.5 years. The maximum study duration for a participant will be 58 months. Participants' safety will be monitored throughout the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy and Safety of JNJ-54861911 in Subjects Who Are Asymptomatic At Risk for Developing Alzheimer's Dementia
Actual Study Start Date : November 23, 2015
Estimated Primary Completion Date : April 10, 2024
Estimated Study Completion Date : April 10, 2024


Arm Intervention/treatment
Experimental: Group 1
Participants will receive one atabecestat, 5 milligram (mg) tablet orally once daily up to 54 months.
Drug: Atabecestat, 5 mg
One atabecestat, 5 mg tablet orally once daily up to 54 months.

Experimental: Group 2
Participants will receive one atabecestat, 25 mg tablet orally once daily up to 54 months.
Drug: Atabecestat, 25 mg
One atabecestat, 25 mg tablet orally once daily up to 54 months.

Experimental: Group 3
Participants will receive one matching placebo tablet orally once daily up to 54 months.
Drug: Placebo
One matching placebo tablet orally once daily up to 54 months.




Primary Outcome Measures :
  1. Change from Baseline in Preclinical Alzheimer Cognitive Composite (PACC) to Month 54 [ Time Frame: Up to Month 54 ]
    The PACC is composed of 4 measures [Free and Cued Selective Reminding Test, Delayed Paragraph Recall, Wechsler Adult Intelligence Scale (WAIS)-IV Coding and Mini Mental State Examination (MMSE) Total Score] that are weighted towards episodic memory and includes a timed executive function test and a global cognitive screening test. Each component score will be transformed into z scores. These z-scores will then be summed to form the composite. Higher scores indicate better performance.


Secondary Outcome Measures :
  1. Change from Baseline in Cognitive Function Index (CFI) to Month 54 [ Time Frame: Up to Month 54 ]
    Cognitive Function Index (CFI) is a 15 point rating scale that assess the Participants perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. The higher scores indicates greater impairment.

  2. Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADLPI) Total Score to Month 54 [ Time Frame: Up to Month 54 ]
    The Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADLPI) is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4 point scale and 3 high level function items. The scores range from 0 to 45 with higher scores indicating less impairment.

  3. Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score to Month 51 [ Time Frame: Up to Month 51 ]

    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) rating scale is used to assess the cognitive assessment, detection, and characterization of dementia. The scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation of 15.

    Higher scores indicating less impairment.


  4. Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score to Month 54 [ Time Frame: Up to Month 54 ]
    The Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores ranging from 0 to 18. The CDR assesses 3 domains of cognition (memory, orientation, judgment/problem solving) and 3 domains of function (community affairs, home/hobbies, personal care) using semistructured interviews of both the study participant and an informant carried out by a trained rater. The Higher CDR-SB scores indicate greater impairment.

  5. Change from Baseline in Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score to Month 54 [ Time Frame: Up to Month 54 ]
    The Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score represent a series of performance based measures covering 5 domains (Attention, Memory, Language, Spatial, and Executive function). Index scores can range from less than or equal to (< =) 55 to greater than or equal to (> =) 145, and are normalized to a mean of 100 and standard deviation of 15. Higher scores indicate less impairment.

  6. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Month 58 ]
    An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  7. Trough Plasma Concentration (Ctrough) of Atabecestat [ Time Frame: Up to Month 54 ]
    The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.

  8. Area Under the Plasma Concentration-Time Curve From 0 to tau Hours After Dosing (AUCtau) [ Time Frame: Up to Month 54 ]
    The AUCtau is the area under the plasma concentration-time curve from time zero to tau hours (time tau is the dosing interval).

  9. Change in mean Cerebral Fibrillar Amyloid Accumulation [ Time Frame: Up to Month 54 ]
    The accumulation of cerebral fibrillar amyloid will be measured by amyloid positron emission tomography (PET) imaging.

  10. Change From Baseline of Neurodegeneration by Assessing Changes in Imaging Biomarkers [ Time Frame: Up to Month 54 ]
    Neurodegeneration will be assessed based on changes in imaging biomarkers.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must have a global Clinical Dementia Rating Scale- (CDR) score of '0' at Screening
  • Participants 60 to 64 years of age must also have 1 of the following 3 conditions: a) a positive family history for dementia (minimum of 1 first degree relative), b) a previously known apolipoprotein E, ε4 allele (APOE ɛ4) genotype, c) a previously known biomarker status demonstrating elevated amyloid accumulation in cerebrospinal fluid (CSF) or positron emission tomography (PET)
  • Participant must be able to read and write and must have adequate hearing and visual acuity to complete the psychometric tests. The legally acceptable representative must also be able to read and write
  • Participants must have evidence of amyloid accumulation by means of either: a) low Cerebrospinal Fluid (CSF) ABeta 1-42 levels at Screening; b) a positive amyloid positron emission tomography (PET) scan at Screening (depending on the site's PET capability) by visual read
  • Participant must be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or at Baseline

Exclusion Criteria:

  • Participant is receiving an acetylcholinesterase (AChE) inhibitor and/or memantine at any time during Screening or Day 1 predose
  • Participant has evidence of any brain diseases, other than potential very early signs of Alzheimer's Dementia (AD) (example. mild hippocampal atrophy) or typical age-related changes (e.g. mild white matter hyperintensity on magnetic resonance imaging [MRI]) or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that could explain a possible cognitive deficit (including, but not limited to vascular encephalopathy or large strokes (as imaged by cerebral MRI)
  • Participant has any contraindications for MRI (example, prostheses, implants, claustrophobia, pacemaker)
  • Participant has met criteria for dementia or has a brain disorder that can cause dementia
  • Participant has evidence of familial autosomal dominant AD (mutation identified in the family and/or participant prior to randomization)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569398


  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham - Alzheimer's Disease Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
Rancho Los Amigos Med Ctr-Pth
Downey, California, United States, 90242
University of California, San Diego
La Jolla, California, United States, 92037
University of California Los Angeles
Los Angeles, California, United States, 90095
Hoag Neuroscience Institute
Newport Beach, California, United States, 92663
University of California Irvine
Orange, California, United States, 92868
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
United States, Connecticut
Alzheimer's Disease Research Unit - Department Of Psychiatry - School Of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown Univ Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Florida Atlantic University
Boca Raton, Florida, United States, 33431
Brain Matters Research
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research Center of SWFL
Fort Myers, Florida, United States, 33912
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States, 32216
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Alzheimers Research and Treatment Center
Lake Worth, Florida, United States, 33449
Compass Research, Melbourne
Melbourne, Florida, United States, 32940
Wien Center for Clinical Research
Miami Beach, Florida, United States, 33140
Sensible Healthcare
Ocoee, Florida, United States, 34761
Compass Research LLC
Orlando, Florida, United States, 32806
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States, 32174
University of South Florida - Health Byrd Alzheimer Institute
Tampa, Florida, United States, 33613
Compass Research, North
The Villages, Florida, United States, 32162
United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Medical Research & Health Education Foundation, Inc.
Columbus, Georgia, United States, 31909
NeuroStudies.net, LLC
Decatur, Georgia, United States, 30033
United States, Illinois
Great Lakes Clinical Trials
Arlington Heights, Illinois, United States, 60004
Rush University Medical Center
Chicago, Illinois, United States, 60612
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Indiana Medical Research
Elkhart, Indiana, United States, 46514
Indiana Univ School Of Med
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa, Carver College of Medicine
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas
Westwood, Kansas, United States, 66205
United States, Kentucky
University of Kentucky, Sanders-Brown Center of Aging
Lexington, Kentucky, United States, 40504
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
United States, Maine
Acadia Hospital
Bangor, Maine, United States, 04402
United States, Massachusetts
Brigham & Women's Hospital / Dept of Medicine
Boston, Massachusetts, United States, 02115
BU Alzheimer's Disease Center
Boston, Massachusetts, United States, 02218
Donald S. Marks, MD., P.C.
Plymouth, Massachusetts, United States, 02360
United States, Michigan
The Regents of the University of Michigan
Ann Arbor, Michigan, United States, 48109
Western Michigan University
Kalamazoo, Michigan, United States, 49008
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
St Louis University Medical Center
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
United States, Nevada
Cleveland Clinic Lou Revo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
United States, New York
Dent Neurologic Institute
Amherst, New York, United States, 14226
Mount Sinai School of Medicine
New York, New York, United States, 10029
The Nathan S. Kline Institute For Psychiatric Research
Orangeburg, New York, United States, 10962
Monroe Comm Hospital
Rochester, New York, United States, 14620
Richmond Behavioural Associates
Staten Island, New York, United States, 10312
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
New Hope Clinical Research
Charlotte, North Carolina, United States, 28211
Alzheimer's Memory Center
Charlotte, North Carolina, United States, 28270
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Lou Revo Center for Brain Health
Cleveland, Ohio, United States, 44195
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
Center for Cognitive Health
Portland, Oregon, United States, 97225
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Brown University School of Medicine
Providence, Rhode Island, United States, 02906
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
United States, Tennessee
Neurology Clinic, PC - 8000 Centerview Parkway, Suite 300
Cordova, Tennessee, United States, 38018
Clinical Research Associates Inc
Nashville, Tennessee, United States, 37203
United States, Texas
Senior Adults Specialty Research, Inc.
Austin, Texas, United States, 78757
University of Texas Southwestern Medical Center At Dallas
Dallas, Texas, United States, 75390
Alzheimer's Disease & Memory Disorder Center, Baylor College of Medicine
Houston, Texas, United States, 77030
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
University of Virginia, Neurology
Charlottesville, Virginia, United States, 22908
United States, Washington
UW Medicine - Harborview Medical Center
Seattle, Washington, United States, 98195
Drg23, PLLC
Spokane, Washington, United States, 99202
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Australia
Royal Adelaide Hospital, Neurologie
Adelaide, Australia, 5000
Queensland University of Technology
Brisbane, Australia, 4222
Saint Vincent's Hospital
Darlinghurst, Australia, 2010
Central Coast Neurosciences Research, Gosford
East Gosford, Australia, 2250
Austin Hospital
Heidelberg, Australia, 3084
Royal Brisbane & Women's Hospital
Herston, Australia, 4029
Australian Alzheimer's Research Foundation Incorporated
Nedlands, Australia, 6009
Neurodegenerative Disorders Research
Subiaco, Australia, 6008
KARA Institute for Neurological Diseases
Tarren Point, Australia
Calvary Mater Newcastle
Waratah, Australia, 2298
Belgium
ZNA Middelheim
Antwerpen, Belgium, 2020
Centre Hospitalier EPICURA Ath-Baudour-Hornu
Baudour, Belgium, 7331
Universitair Ziekenhuis Brussel
Brussel, Belgium, 1090
U.Z. Antwerpen
Edegem, Belgium, 2650
C. H. U. Sart Tilman
Liège, Belgium, 4000
CHU Ambroise Paré
Mons, Belgium, 7000
Canada
Recherches Neuro-Hippocampe Inc.
Gatineau, Canada, J8T 8J1
Toronto Memory Program (Neurology Research Inc.)
Toronto, Canada, M3B 257
Denmark
CCBR - Ålborg - DK
Aalborg, Denmark, 9100
CCBR - Ballerup - DK
Ballerup, Denmark, 2750
Rigshospitalet - Hukommelses Klinikken
København Ø, Denmark, 2100
CCBR - Vejle - DK
Rødovre, Denmark
Finland
Itä-Suomen yliopisto, Kuopion kampus
Kuopio N/A, Finland, 70210
PET-keskus / CRST
Turku, Finland, 20521
Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12203
Universitaetsklinikum Bonn AoeR, Neurologie
Bonn, Germany, 53127
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09131
Universitaetsklinikum Essen
Essen, Germany, 45147
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06112
Universitaetsklinikum des Saarlandes
Homburg, Germany, 66421
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, Germany, D-24105
Klinik für Psychiatrie, Zentrum für Gedächtnisstörungen
Köln, Germany, 50937
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim, Germany, 68165
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, Germany, 09648
Neurozentrum Sophienstrasse
Stuttgart, Germany, 70178
Universitätsklinik Ulm
Ulm, Germany, 89081
Institute Of Neuropsychiatry And Neuropsychology
Wenzenbach, Germany, 93173
Universitaetsklinikum Wuerzburg
Wuerzburg, Germany, 97080
Italy
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, Italy, 16132
Azienda Ospedaliera San Gerardo
Monza, Italy, 20090
Seconda Università degli Studi di Napoli, Neurologica
Napoli, Italy, 80138
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Ospedale degli Infermi
Ponderano, Italy, 13875
Universita "La Sapienza" - Clinico Psiciatrico
Roma, Italy, 00185
Japan
Inage Neurology and Memory Clinic
Chiba-Shi, Japan, 263-0043
Fukuoka University Hospital
Fukuoka-Shi, Japan
Soseikai Sugioka Memorial Hospital
Fukuoka-Shi, Japan
Keikokai P-One Clinic
Hachioji-Shi, Japan
Izuka Hospital
Iizuka-Shi, Japan
Kyosokai Amc Nishiumeda Clinic
Osaka-Shi, Japan
Eireika Tokyo Headache Clinic
Shibuya-Ku, Japan
Clinical Research Hospital Tokyo
Shinjuku-Ku, Japan, 162-0053
JCHO Tokyo Shinjuku Medical Center
Shinjuku-Ku, Japan
Shinjuku Research Park Clinic
Shinjuku-Ku, Japan
Jisenkai Nanko Psychiatric Institute
Shirakawa, Japan
Sumida Hospital
Tokyo, Japan, 130-0004
Mexico
Unidad de Investigacion en Salud de Chihuahua SC, Sede Chihuahua
Chihuahua, Mexico, 31203
Centro de Estudios Clinicos y Especialidades Medicas, S.C.
Monterrey, Mexico, 64620
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosi, Mexico, 78240
Clinical Research Institute S.C.
Tlalnepantla De Baz, Mexico, 54055
Netherlands
Alzheimer Research Center
Amsterdam, Netherlands, 1081 GM
Amphia Ziekenhuis, Dept Neurology
Breda, Netherlands, 4818 CK
Jeroen Bosch Ziekenhuis
S-Hertogenbosch, Netherlands, 5223 GZ
EB Utrecht
Utrecht, Netherlands, 3511 NH
Spain
Fundacio Pasqual Maragall
Barcelona, Spain, 08005
Fundacio ACE
Barcelona, Spain, 08028
Hospital Universitari Quiron Dexeus
Barcelona, Spain, 08028
CAE Oroitu
Getxo, Spain, 48993
Clínica Rúber
Madrid, Spain, 28006
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
ALTHAIA Hospital Sant Joan de Deu
Manresa, Spain, 08243
Hosp. Univ. Central de Asturias
Oviedo, Spain
Fundación CITA Alzheimer
San Sebastian, Spain
Hosp. Ntra. Sra. de La Candelaria
Santa Cruz De Tenerife, Spain, 38010
Hosp. Virgen Macarena
Sevilla, Spain
Hospital Universitario Mutua de Terrasa
Terrassa, Spain, 08221
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Sweden
Sahlgrenska Universitetssjukhuset Mölndal Sjukhus
Mölndal, Sweden, 43141
United Kingdom
Re-Cognition Health
Birmingham, United Kingdom, B16 8LT
Royal Devon & Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
Glasgow Memory Clinic Ltd
Glasgow, United Kingdom, GB:G20 0XA
Cognition Health Clinical Trials Centre
Guildford, United Kingdom, GU2 7RF
Barts Hospital
London, United Kingdom, EC1A 7BE
Cognition Health Ltd
London, United Kingdom, W1G 9JF
The National Hospital for Neurology and Neurosurgery Centre
London, United Kingdom, WC1N 3BG
Newcastle University
Newcastle Upon Tyne, United Kingdom, NE4 5PL
Re-Cognition Health
Plymouth, United Kingdom
Univeristy of sheffield & sheffield teaching hospital NHS trust
Shefield, United Kingdom, S10 2HQ
Kingshill Research Centre
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02569398     History of Changes
Other Study ID Numbers: CR107373
2015-000948-42 ( EudraCT Number )
54861911ALZ2003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Alzheimer disease
Atabecestat
Dementia

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases