Trials Sponsors Conditions Drugs Pricing

Conditions

Alzheimer's Disease (AD)Mild Cognitive Impairment (MCI)

Keywords

amyloidplaquesneuroimagingbiomarkerscognition disorderearly detectionpre-dementiadementiaAlzheimer's diseasetau

Outcome Measures

Primary Outcomes (3)

Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)
The ADAS-Cog is an in-person examiner-administered, structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained.
5 years
Rate of change in cognition as measured by the Logical Memory Test I and II
5 years
Rate of change in cognition as measured by the Mini-Mental State Examinations (MMSE)
The MMSE scale evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons.

Study Arms (3)

Cognitively Normal (CN)

135-500 newly enrolled participants with no apparent memory problems, and 295-300 cognitively normal participants followed from the ADNI2 study. Currently recruiting non-Caucasian participants only for the normal cognition group.

Mild Cognitive Impairment (MCI)

150 - 515 newly enrolled participants with mild cognitive impairment (MCI), and 275-320 MCI participants followed from the ADNI2 study.

Mild Alzheimer's Disease (AD) dementia

85 - 185 newly enrolled participants with mild Alzheimer's disease (AD) dementia, and 130 - 150 mild AD participants followed from the ADNI2 study.

Eligibility Criteria

Age55 Years - 90 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Cognitively normal (CN), mild cognitive impairment (MCI), and mild AD dementia participants.

You may qualify if:

Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age

Sponsors & Collaborators

Alzheimer's Therapeutic Research Institute
Othercollaborator
Northern California Institute of Research and Education
Othercollaborator

Study Sites (59)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

University of California, Irvine

Irvine, California, 92697, United States

University of California, San Diego

La Jolla, California, 920371707, United States

Long Beach VA Neuropsychiatric Research Program

Related Publications (7)

Howe MD, Zide BS, Hayes K, Ross D, Barker MS, Kunicki ZJ, Rudolph J, Huey E. Symptom-Guided Blood Biomarker Testing for Alzheimer's Disease. Dement Geriatr Cogn Disord. 2026 Oct 12:1. doi: 10.1159/dem/aciag010. Online ahead of print.
PMID: 42862762DERIVED
Miller AA, Sharp ES, Wang S, Zhao Y, Mecca AP, van Dyck CH, O'Dell RS; Alzheimer's Disease Neuroimaging Initiative (ADNI). Self-reported hearing loss is associated with faster cognitive and functional decline but not diagnostic conversion in the ADNI cohort. Alzheimers Dement. 2024 Nov;20(11):7847-7858. doi: 10.1002/alz.14252. Epub 2024 Sep 26.
PMID: 39324520DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, cerebrospinal fluid

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseasePlaque, AmyloidCognition DisordersDementiaPick Disease of the Brain

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

Michael W. Weiner, MD
University of California, San Francisco
STUDY DIRECTOR
Paul Aisen, MD
USC Alzheimer's Therapeutic Research Institute (ATRI)
PRINCIPAL INVESTIGATOR
Ronald Peterson, MD, PHD
Mayo Clinic
PRINCIPAL INVESTIGATOR

Enrollment

1,141 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director, Alzheimer's Therapeutic Research Institute

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 3, 2016

Study Start

December 2, 2016

Actual (reported)

You may not qualify if:

Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
\. Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
\. Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
Screening/Baseline MRI brain scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure
Subjects that have any contraindications for MRI studies, including the presence of cardiac pacemakers, or metal fragments or foreign objects in the eyes, skin or body.
Major depression, bipolar disorder as described in DSM-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol.
Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
History of schizophrenia (DSM IV criteria).
History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol.
Residence in a skilled nursing facility.
Investigational agents are prohibited one month prior to entry and for the duration of the trial.
Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided.
Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject's participation in the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females.

Alzheimer's Disease Neuroimaging Initiative 3

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (3)

Cognitively Normal (CN)

Mild Cognitive Impairment (MCI)

Mild Alzheimer's Disease (AD) dementia

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (59)

Related Publications (7)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (12)

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (3)

Cognitively Normal (CN)

Mild Cognitive Impairment (MCI)

Mild Alzheimer's Disease (AD) dementia

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (59)

Related Publications (7)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (12)

You may not qualify if:

Data Sharing

Source record

Documents

Locations