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A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (GS1)

Primary Purpose

Alzheimers Disease

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CAD106 Immunotherapy

Placebo to CAD106

CNP520

Placebo to CNP520

Alum

About this trial

This is an interventional treatment trial for Alzheimers Disease focused on measuring Randomization, Placebo controlled, Parallel-group, APOE4 Homozygotes, Preclinical Alzheimers Disease (AD), Aβ lowering, CNP520, CAD106, elderly, Brain Amyloid, BACE-1 inhibitor, Prevention, Unimpaired cognition

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Consented to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype.
Male or female, age 60 to 75 years inclusive. Females were to be post-menopausal.
Mini-Mental State Examination (MMSE) total score ≥ 24 and cognitively unimpaired as evaluated by memory tests
Homozygous APOE4 genotype.
Participant willing to have a study partner.

Key Exclusion Criteria:

Any disability that prevented the participant from completing all study requirements.
Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
Advanced, severe progressive or unstable disease that may have interfered with the safety, tolerability and study assessments, or put the participant at special risk.
History of malignancy of any organ system, treated or untreated, within 60 months prior to screening.
History of hypersensitivity to any of the investigational drugs or their excipients / adjuvant or to drugs of similar chemical classes.
Indication or on current treatment with ChEIs and/or another AD treatment (e.g. memantine).
Contraindication or intolerance to MRI or PET investigations (with fluorinated radio ligands).
Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator could have been a leading cause to future cognitive decline, pose a risk to the participant, or prevent a satisfactory MRI assessment for safety monitoring.
Suicidal Ideation in the past six months or Suicidal Behavior in the past two years, prior to screening.
A positive drug screen at Screening, if, in the Investigator's opinion, this was due to drug abuse.
Significantly abnormal laboratory results at Screening, or infection not as a result of a temporary condition.
Current clinically significant ECG findings. For Cohort - I only: Participants with previous organ transplantation or stem cell transplantation, or indication for treatment with anti-coagulants.

For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g. albinism vitiligo) or active / history of chronic urticarial in the past year.

Sites / Locations

Banner Alzheimer's Institute
Novartis Investigative Site
Novartis Investigative Site
Banner Sun City Research Institute
ATP Clinical Research, Inc.
Irvine Center for Clinical Research
University of Southern California Keck School of Medicine Alzheimer Disease Research Center
Novartis Investigative Site
Novartis Investigative Site
Syrentis Clinical Research
Novartis Investigative Site
California Neuroscience Research Medical Group, Inc.
Novartis Investigative Site
Novartis Investigative Site
Yale University Alzheimer's Disease Research Unit
New England Institute for Clinical Research
Georgetown University
Novartis Investigative Site
JEM Research Institute
Florida Atlantic University, Clinical Translational Research Unit
Brain Matters Research
Novartis Investigative Site
Meridien Research
Merritt Island Medical Research
Mount Sinai Medical Center - The Wien Center
University of Miami
Novartis Investigative Site
Compass Research
Progressive Medical Research
USF Health Byrd Alzheimer's Institute
Novartis Investigative Site
Medical Research & Health Education Foundation, Inc.
NeuroStudies
Advanced Clinical Research
Rush University Medical Center
Great Lakes Clinical Trials
Indiana University
University of Kansas Alzheimer's Disease Center
Via Christi Research
Sanders Brown Center on Aging, University of Kentucky
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Memory Disorders Program, Department of Neurological Sciences, University of Nebraska Medical Center
Cleveland Clinic Lou Ruvo Center for Brain Health
Memory Enhancement Center
The Memory Center of Northeastern New York
NYU Langone Medical Center
The Nathan S. Kline Institute
University of Rochester Medical Center
Alzheimer's Memory Center
Duke University Medical center
Triad Clinical Trials, LLC
University Hospitals Cleveland Medical Center / Case Western Reserve University
Novartis Investigative Site
Novartis Investigative Site
IPS Research Company
Novartis Investigative Site
Memory Health Center at Summit Research Network
The Clinical Trial Center, LLC
Novartis Investigative Site
Abington Neurological Associates
Butler Hospital Memory and Aging Program
Roper St. Francis - CBRI
Novartis Investigative Site
CNS Healthcare
Novartis Investigative Site
Senior Adults Specialty Research
Kerwin Research Center & Memory Care
Houston Methodist Hospital
University of Texas Health Science Center, Houston
Clinical Trial Network
The Memory Clinic
Universal Research Group
The Medical College of WI
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Okanagan Clinical Trials
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Toronto Memory Program
The Centre for Memory and Aging
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort I (CAD106)

Cohort I (CAD106 Placebo)

Cohort II (CNP520)

Cohort II (CNP520 Placebo)

Arm Description

CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter

Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter

CNP520 (50 mg) capsules taken orally once daily

Matching Placebo to CNP520 capsules taken orally once daily

Outcomes

Primary Outcome Measures

Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))

Event was defined as the first confirmed diagnosis of MCI due to Alzheimer's disease (AD) or dementia due to AD (whichever occurred first) after adjudication by the progression adjudication committee (PAC) as triggered either by an investigator diagnosis or an increase in the Clinical Dementia Rating (CDR) global score. An event had to be confirmed by the PAC at two consecutive visits. In case no confirmed event was observed for a participant, the observation was censored, and the censoring date was defined as the last date where the diagnostic classification was assessed. The Study was terminated and only confirmed events collected up to the data cut-off point were counted. Due to the early termination of the study only a small number of events were observed and time-to-event could not be analyzed. Kaplan-Meyer (KM) estimates were provided to estimate probability that a subject would have an event prior to the specified visit.

Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score

APCC is a composite score derived from the specific scores from the Repeatable Battery for the Assessment of Neurological Status (RBANS), Mini-Mental State Examination (MMSE) and the Raven's Progressive Matrices. The APCC score is a weighted score with ranges from from 0 to 100 where higher scores correspond to better cognitive performance.

Secondary Outcome Measures

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score

The CDR was obtained through semi-structured interviews of participants and informants, and cognitive functioning was rated on a 5-point scale of functioning in six domains: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. The CDR global score ranged from zero to three, while the CDR-SOB was the sum of the ratings from the six domains, ranging from 0 to 18 with a minimum increment of 0.5. Higher scores indicated greater disease severity.

Change in the Total Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

Repeatable Battery for the Assessment of Neurological Status (RBANS) is a clinical tool designed to detect and characterize the earliest neurocognitive changes associated with dementia. The RBANS generates age-adjusted index scores for five neurocognitive domains: Immediate Memory, Visuospatial/Constructional, Language, Attention and Delayed Memory, which are used to calculate a Total Scale Index score. Index scores and total score range from 40 to 160 and a higher score indicates better cognitive functioning.

Change in the Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

Change in the Everyday Cognition Scale (ECog-Subject) Total Scores

Everyday Cognition Scale (ECog) measures cognitively-relevant everyday abilities comprised of 39 items covering 6 cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. The questionnaire is a self-reported measure completed by both participant and study partner (informant). The total score for the 39 items ranges from 39 to 195, with greater scores indicating worse daily function.

Change in the Everyday Cognition Scale (ECog-Informant) Total Scores

Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)

Safety MRI included sequences necessary for ascertainment of possible ARIA-E (Amyloid Related Imaging Abnormality-Edema), ARIA-H (Amyloid Related Imaging Abnormality- Hemorrhage, including superficial siderosis and microhemorrhages), assessment of recent infarcts and white matter integrity examination (White matter disease worsening since baseline) and a general assessment of brain abnormalities. Assessment of cerebral amyloid angiopathy (CAA) is included in the overall safety MRI findings results.

Annualized Percent Change on Volume of Brain Regions

Annualized % change from baseline in volume of specific brain regions of interest (ROIs): whole brain (WB), hippocampus (Hip), and lateral ventricles (LV). Annualized percentage change was calculated as (percentage per participant / time interval (in days)) x 365.25. Time interval (in days) was derived as date of current MRI assessment on study drug - date of baseline MRI assessment + 1.

Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 40 (Aβ40)

Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40)

Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 42 (Aβ42)

Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42)

Change in Cerebrospinal Fluid (CSF) Levels of Total Tau and Phosphorylated Tau

Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels

Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)

To demonstrate the effects of CNP520 vs placebo on tau pathology in the brain

Cohort I : Annualized Change in Amyloid Deposition as Measured by Centiloids of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer

To demonstrate the effects of CAD106 vs placebo on Alzheimer's Disease-related biomarkers

Change in Serum Neurofilaments

Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)

Number of Suicidal Ideation or Behavior Events

Prospective suicidality assessment was performed with the use of Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire using a detailed branched logic algorithm evaluating participant's suicidality ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section was considered positive.

Cohort I : Change in Cognition as Measured by APCC and CDR-SOB Scores and Antibody Response

Cohort I: Peak Concentration (Cmax) of CAD106 Induced Abeta-specific Antibody Titers

Cmax is the maximum Titer Concentration of any post-baseline 'on treatment' visit. A visit is considered as 'on treatment' if visit date is within {last injection + 180 days}. - Geometric mean and CI's are back-transformed from the estimates for Log mean and CI's.

Cohort I: Area Under the Concentration Curve (AUC) of CAD106 Induced Abeta-specific Antibody Titers

AUC is calculated based on 'on treatment' visit only.(missing values for peak visits were linearly interpolated for calculation; missing values for trough visits were imputed by average of non-missing trough values.).

Full Information

NCT ID

NCT02565511

First Posted

September 28, 2015

Last Updated

July 7, 2021

Sponsor

Novartis Pharmaceuticals

Collaborators

Banner Alzheimer's Institute, National Institute on Aging (NIA), Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02565511

Brief Title

A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

Acronym

GS1

Official Title

A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Study Start Date

November 30, 2015 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

Collaborators

Banner Alzheimer's Institute, National Institute on Aging (NIA), Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to test whether two investigational drugs called CAD106 and CNP520, administered separately, could slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

Detailed Description

The study (also known as the Generation Study 1, GS1) was conducted as part of the Alzheimer's Prevention Initiative (API) program. This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired APOE4 homozygotes (HMs) aged 60 to 75 years. Participants were enrolled into Cohort I (CAD106) or Cohort II (CNP520). The planned treatment period of 5 to 8 years was not achieved due to early study termination. The study was terminated due to unexpected changes in cognitive function, brain volume loss, and body weight loss. Cohort II (CNP520) treatment was stopped and evaluated through an off-treatment follow-up period. After the decision to terminate Cohort II of the study (CNP520), treatment with CAD106 (Cohort I) was also terminated.

6. Conditions and Keywords

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

Alzheimers Disease

Keywords

Randomization, Placebo controlled, Parallel-group, APOE4 Homozygotes, Preclinical Alzheimers Disease (AD), Aβ lowering, CNP520, CAD106, elderly, Brain Amyloid, BACE-1 inhibitor, Prevention, Unimpaired cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort I (CAD106)

Arm Type

Experimental

Arm Description

CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter

Arm Title

Cohort I (CAD106 Placebo)

Arm Type

Placebo Comparator

Arm Description

Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter

Arm Title

Cohort II (CNP520)

Arm Type

Experimental

Arm Description

CNP520 (50 mg) capsules taken orally once daily

Arm Title

Cohort II (CNP520 Placebo)

Arm Type

Placebo Comparator

Arm Description

Matching Placebo to CNP520 capsules taken orally once daily

Intervention Type

Biological

Intervention Name(s)

CAD106 Immunotherapy

Intervention Description

Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.

Intervention Type

Other

Intervention Name(s)

Placebo to CAD106

Intervention Description

Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.

Intervention Type

Drug

Intervention Name(s)

CNP520

Intervention Description

CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.

Intervention Type

Other

Intervention Name(s)

Placebo to CNP520

Intervention Description

Placebo to CNP520 p.o. for the duration of the Treatment Epoch

Intervention Type

Other

Intervention Name(s)

Alum

Intervention Description

Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106

Primary Outcome Measure Information:

Title

Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))

Description

Time Frame

Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

Title

Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score

Description

Time Frame

CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment

Secondary Outcome Measure Information:

Title

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score

Description

Time Frame

CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment

Title

Change in the Total Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

Description

Time Frame

CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment

Title

Change in the Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

Description

Time Frame

CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment

Title

Change in the Everyday Cognition Scale (ECog-Subject) Total Scores

Description

Time Frame

CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment

Title

Change in the Everyday Cognition Scale (ECog-Informant) Total Scores

Description

Time Frame

CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment

Title

Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)

Description

Time Frame

Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

Title

Annualized Percent Change on Volume of Brain Regions

Description

Time Frame

CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment

Title

Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 40 (Aβ40)

Description

Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40)

Time Frame

Baseline to last assessment

Title

Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 42 (Aβ42)

Description

Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42)

Time Frame

Baseline to last assessment

Title

Change in Cerebrospinal Fluid (CSF) Levels of Total Tau and Phosphorylated Tau

Description

Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels

Time Frame

Baseline to last assessment

Title

Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)

Description

To demonstrate the effects of CNP520 vs placebo on tau pathology in the brain

Time Frame

Baseline to last assessment

Title

Cohort I : Annualized Change in Amyloid Deposition as Measured by Centiloids of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer

Description

To demonstrate the effects of CAD106 vs placebo on Alzheimer's Disease-related biomarkers

Time Frame

Baseline up to approximately Week 104

Title

Change in Serum Neurofilaments

Description

Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)

Time Frame

Baseline to Week 26 and week 52, CI baseline to last assessment. CII baseline to last on-treatment and to last off-treatment

Title

Number of Suicidal Ideation or Behavior Events

Description

Time Frame

Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

Title

Cohort I : Change in Cognition as Measured by APCC and CDR-SOB Scores and Antibody Response

Time Frame

Month 6 to Month 60

Title

Cohort I: Peak Concentration (Cmax) of CAD106 Induced Abeta-specific Antibody Titers

Description

Time Frame

Week 9, 13, 15, 26 and quarterly thereafter (trough values)

Title

Cohort I: Area Under the Concentration Curve (AUC) of CAD106 Induced Abeta-specific Antibody Titers

Description

Time Frame

Week 9, 13, 15, 26 and quarterly thereafter (trough values)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Consented to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype. Male or female, age 60 to 75 years inclusive. Females were to be post-menopausal. Mini-Mental State Examination (MMSE) total score ≥ 24 and cognitively unimpaired as evaluated by memory tests Homozygous APOE4 genotype. Participant willing to have a study partner. Key Exclusion Criteria: Any disability that prevented the participant from completing all study requirements. Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments. Advanced, severe progressive or unstable disease that may have interfered with the safety, tolerability and study assessments, or put the participant at special risk. History of malignancy of any organ system, treated or untreated, within 60 months prior to screening. History of hypersensitivity to any of the investigational drugs or their excipients / adjuvant or to drugs of similar chemical classes. Indication or on current treatment with ChEIs and/or another AD treatment (e.g. memantine). Contraindication or intolerance to MRI or PET investigations (with fluorinated radio ligands). Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator could have been a leading cause to future cognitive decline, pose a risk to the participant, or prevent a satisfactory MRI assessment for safety monitoring. Suicidal Ideation in the past six months or Suicidal Behavior in the past two years, prior to screening. A positive drug screen at Screening, if, in the Investigator's opinion, this was due to drug abuse. Significantly abnormal laboratory results at Screening, or infection not as a result of a temporary condition. Current clinically significant ECG findings. For Cohort - I only: Participants with previous organ transplantation or stem cell transplantation, or indication for treatment with anti-coagulants. For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g. albinism vitiligo) or active / history of chronic urticarial in the past year.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Banner Alzheimer's Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Novartis Investigative Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Banner Sun City Research Institute

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

Irvine Center for Clinical Research

City

Irvine

State/Province

California

ZIP/Postal Code

92614

Country

United States

Facility Name

University of Southern California Keck School of Medicine Alzheimer Disease Research Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Novartis Investigative Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Syrentis Clinical Research

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Novartis Investigative Site

City

Sebastopol

State/Province

California

ZIP/Postal Code

95472

Country

United States

Facility Name

California Neuroscience Research Medical Group, Inc.

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91316

Country

United States

Facility Name

Novartis Investigative Site

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Facility Name

Novartis Investigative Site

City

Basalt

State/Province

Colorado

ZIP/Postal Code

81621

Country

United States

Facility Name

Yale University Alzheimer's Disease Research Unit

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

New England Institute for Clinical Research

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Georgetown University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20059

Country

United States

Facility Name

JEM Research Institute

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462-6608

Country

United States

Facility Name

Florida Atlantic University, Clinical Translational Research Unit

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33431

Country

United States

Facility Name

Brain Matters Research

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Meridien Research

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Merritt Island Medical Research

City

Merritt Island

State/Province

Florida

ZIP/Postal Code

32952

Country

United States

Facility Name

Mount Sinai Medical Center - The Wien Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Compass Research

City

Orlando

State/Province

Florida

ZIP/Postal Code

32812

Country

United States

Facility Name

Progressive Medical Research

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

USF Health Byrd Alzheimer's Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Medical Research & Health Education Foundation, Inc.

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31909

Country

United States

Facility Name

NeuroStudies

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Advanced Clinical Research

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Great Lakes Clinical Trials

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Kansas Alzheimer's Disease Center

City

Fairway

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Via Christi Research

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Sanders Brown Center on Aging, University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Novartis Investigative Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49008

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55130

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Memory Disorders Program, Department of Neurological Sciences, University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-7680

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

Memory Enhancement Center

City

Eatontown

State/Province

New Jersey

ZIP/Postal Code

07724

Country

United States

Facility Name

The Memory Center of Northeastern New York

City

Latham

State/Province

New York

ZIP/Postal Code

12110

Country

United States

Facility Name

NYU Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

The Nathan S. Kline Institute

City

Orangeburg

State/Province

New York

ZIP/Postal Code

10962

Country

United States

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

Facility Name

Alzheimer's Memory Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28270

Country

United States

Facility Name

Duke University Medical center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Triad Clinical Trials, LLC

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27410

Country

United States

Facility Name

University Hospitals Cleveland Medical Center / Case Western Reserve University

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Novartis Investigative Site

City

Centerville

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

IPS Research Company

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

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

The Clinical Trial Center, LLC

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Abington Neurological Associates

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Butler Hospital Memory and Aging Program

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Roper St. Francis - CBRI

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

Country

United States

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

CNS Healthcare

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

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 & Memory Care

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Houston Methodist Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Texas Health Science Center, Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

Clinical Trial Network

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

The Memory Clinic

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

Universal Research Group

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

The Medical College of WI

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Novartis Investigative Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg Heights

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Okanagan Clinical Trials

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y1Z9

Country

Canada

Facility Name

Novartis Investigative Site

City

Kentville

State/Province

Nova Scota

ZIP/Postal Code

B4N 4K9

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3S 1M7

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6C 0A7

Country

Canada

Facility Name

Toronto Memory Program

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3B 2S7

Country

Canada

Facility Name

The Centre for Memory and Aging

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8T 8J1

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1J 2G2

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Boblingen

ZIP/Postal Code

71032

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04107

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

68159

Country

Germany

Facility Name

Novartis Investigative Site

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Wenzenbach

ZIP/Postal Code

93173

Country

Germany

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 GN

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

Facility Name

Novartis Investigative Site

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08005

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08014

Country

Spain

Facility Name

Novartis Investigative Site

City

Donostia-San Sebastian

ZIP/Postal Code

20009

Country

Spain

Facility Name

Novartis Investigative Site

City

Basel

State/Province

ZIP/Postal Code

4002

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Westbruy On Trym

State/Province

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Exeter

State/Province

Devon

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8BT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Guildford

State/Province

Surrey

ZIP/Postal Code

GU27YD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Avon

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B16 8QQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 8AD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W1G 9JF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W2 1PG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Links:

URL

https://www.generationprogram.com

Description

Generation Program web site

Learn more about this trial

A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

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