Alzheimers Disease Clinical Trial
— GS2Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).
Verified date | August 2021 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.
Status | Terminated |
Enrollment | 1145 |
Est. completion date | March 26, 2020 |
Est. primary completion date | March 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 75 Years |
Eligibility | Inclusion Criteria: - consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid. - Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential - Cognitively unimpaired as evaluated by memory tests performed at screening. - Participant's willingness to have a study partner. - Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging). Exclusion Criteria: - Any disability that could have prevented the participants 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 could 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 the past 60 months. - Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine). - Contraindication or intolerance to MRI. - Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring. - Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years. - A positive drug screen at Screening, if, in the Investigator's opinion, was is due to drug abuse. - Significantly abnormal laboratory results at Screening, not as a result of a temporary condition. - Current clinically significant ECG findings. - Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year. |
Country | Name | City | State |
---|---|---|---|
Argentina | Novartis Investigative Site | Buenos Aires | |
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Australia | Novartis Investigative Site | Darlinghurst | New South Wales |
Australia | Novartis Investigative Site | Heidelberg West | Victoria |
Australia | Novartis Investigative Site | Nedlands | Western Australia |
Belgium | Novartis Investigative Site | Gent | |
Belgium | Novartis Investigative Site | Leuven | |
Canada | Novartis Investigative Site | Gatineau | Quebec |
Canada | Novartis Investigative Site | Greenfield Park | Quebec |
Canada | Novartis Investigative Site | Halifax | Nova Scotia |
Canada | Novartis Investigative Site | Kelowna | British Columbia |
Canada | Novartis Investigative Site | Kentville | Nova Scota |
Canada | Novartis Investigative Site | Ottawa | Ontario |
Canada | Novartis Investigative Site | Quebec | |
Canada | Novartis Investigative Site | Toronto | Ontario |
Canada | Novartis Investigative Site | Toronto | Ontario |
Canada | Toronto Memory Program, 1 Valleybrook Drive Suite 400 | Toronto | Ontario |
Chile | Novartis Investigative Site | Santiago | |
Chile | Novartis Investigative Site | Santiago | |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Guangdong | |
China | Novartis Investigative Site | Shanghai | Shanghai |
Finland | Novartis Investigative Site | Kuopio | |
Finland | Novartis Investigative Site | Turku | |
France | Novartis Investigative Site | Lille Cedex | |
France | Novartis Investigative Site | PARIS Cedex 13 | |
France | Novartis Investigative Site | Rouen | |
France | Novartis Investigative Site | Strasbourg | Cedex |
France | Novartis Investigative Site | Toulouse Cedex 9 | |
France | Novartis Investigative Site | Villeurbanne | |
Germany | Novartis Investigative Site | Bayreuth | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Koeln | |
Germany | Novartis Investigative Site | Leipzig | |
Germany | Novartis Investigative Site | Mannheim | |
Germany | Novartis Investigative Site | Siegen | |
Iceland | Novartis Investigative Site | Kopavogi | |
Israel | Novartis Investigative Site | Ashkelon | |
Israel | Novartis Investigative Site | Haifa | |
Israel | Novartis Investigative Site | Petach Tikva | |
Israel | Novartis Investigative Site | Ramat Gan | |
Israel | Novartis Investigative Site | Tel Aviv | |
Italy | Novartis Investigative Site | Brescia | BS |
Italy | Novartis Investigative Site | Milan | |
Italy | Novartis Investigative Site | Monza | MB |
Italy | Novartis Investigative Site | Roma | Lazio |
Japan | Novartis Investigative Site | Bunkyo ku | Tokyo |
Japan | Novartis Investigative Site | Bunkyo ku | Tokyo |
Japan | Novartis Investigative Site | Chiba | |
Japan | Novartis Investigative Site | Fukuoka city | Fukuoka |
Japan | Novartis Investigative Site | Kodaira | Tokyo |
Japan | Novartis Investigative Site | Osaka | |
Japan | Novartis Investigative Site | Shinjuku-ku | Tokyo |
Japan | Novartis Investigative Site | Suita city | Osaka |
Japan | Novartis Investigative Site | Toon | Ehime |
Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
Korea, Republic of | Novartis Investigative Site | Busan | |
Korea, Republic of | Novartis Investigative Site | Incheon | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Suwon | Gyeonggi Do |
Mexico | Novartis Investigative Site | Ciudad de Mexico | Mexico CP |
Mexico | Novartis Investigative Site | Culiacan | Sinaloa |
Mexico | Novartis Investigative Site | Monterrey | Nuevo Leon |
Netherlands | Novartis Investigative Site | Amsterdam | |
Netherlands | Novartis Investigative Site | Den Bosch | Noord Brabant |
Portugal | Novartis Investigative Site | Coimbra | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Matosinhos | |
Portugal | Novartis Investigative Site | Torres Vedras | Lisbon |
Puerto Rico | Inspira Clinical Research, Ave Hostos 405 | San Juan | |
Singapore | Novartis Investigative Site | Singapore | |
South Africa | Novartis Investigative Site | Cape Town | Western Cape |
South Africa | Novartis Investigative Site | George | ZAF |
South Africa | Novartis Investigative Site | Rosebank | Johannesburg |
Spain | Novartis Investigative Site | Barcelona | |
Spain | Novartis Investigative Site | Barcelona | |
Spain | Novartis Investigative Site | Donostia-San Sebastian | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Pozuelo de Alarcon | Madrid |
Spain | Novartis Investigative Site | Terrassa | Barcelona |
Switzerland | Novartis Investigative Site | Basel | CH |
Switzerland | Novartis Investigative Site | Geneve | |
Switzerland | Novartis Investigative Site | Lausanne | |
Taiwan | Novartis Investigative Site | Kaoshiung | |
Taiwan | Novartis Investigative Site | New Taipei City | |
Taiwan | Novartis Investigative Site | Taipei | |
United Kingdom | Novartis Investigative Site | Avon | |
United Kingdom | Novartis Investigative Site | Birmingham | |
United Kingdom | Novartis Investigative Site | Bristol | |
United Kingdom | Novartis Investigative Site | Dundee | |
United Kingdom | Novartis Investigative Site | Exeter | Devon |
United Kingdom | Novartis Investigative Site | Glasgow | |
United Kingdom | Novartis Investigative Site | Guildford | Surrey |
United Kingdom | Novartis Investigative Site | London | GBR |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | Plymouth | Devon |
United States | Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209 | Albuquerque | New Mexico |
United States | Novartis Investigative Site | Atlanta | Georgia |
United States | Novartis Investigative Site | Atlantis | Florida |
United States | Novartis Investigative Site | Austin | Texas |
United States | Novartis Investigative Site | Bangor | Maine |
United States | Mountain Neurological Research, 350 Market Street, Suite 316 | Basalt | Colorado |
United States | Novartis Investigative Site | Bennington | Vermont |
United States | Novartis Investigative Site | Boston | Massachusetts |
United States | Novartis Investigative Site | Boston | Massachusetts |
United States | Novartis Investigative Site | Brooklyn | New York |
United States | Roper Hospital, 316 Calhoun Street 5th Floor | Charleston | South Carolina |
United States | ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road | Charlotte | North Carolina |
United States | Novartis Investigative Site | Chicago | Illinois |
United States | Novartis Investigative Site | Chicago | Illinois |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100 | Colorado Springs | Colorado |
United States | Novartis Investigative Site | Columbus | Georgia |
United States | ATP Clinical Research Inc, 3151 Airway Avenue T 3 | Costa Mesa | California |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Decatur | Georgia |
United States | Quantum Laboratories | Deerfield Beach | Florida |
United States | Brain Matters Research, Inc., 800 NW 17th Avenue | Delray Beach | Florida |
United States | Denver Neurological Clinic, 950 E Harvard Ave | Denver | Colorado |
United States | Novartis Investigative Site | Durham | North Carolina |
United States | Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave | East Providence | Rhode Island |
United States | Novartis Investigative Site | East Syracuse | New York |
United States | Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock | Elk Grove Village | Illinois |
United States | Novartis Investigative Site | Fairway | Kansas |
United States | QUEST Research Institute, 28595 Orchard Lake Road, Suite 301 | Farmington Hills | Michigan |
United States | Novartis Investigative Site | Greensboro | North Carolina |
United States | Hattiesburg Clinic, 415 South 28th Avenue | Hattiesburg | Mississippi |
United States | Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200 | Hollywood | Florida |
United States | Hawaii Pacific Neuroscience, 2230 Liliha st 104 | Honolulu | Hawaii |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Indianapolis | Indiana |
United States | Irvine Center for Clinical Res, 2515 McCabe Way | Irvine | California |
United States | Novartis Investigative Site | Jenkintown | Pennsylvania |
United States | Novartis Investigative Site | Kalamazoo | Michigan |
United States | Novartis Investigative Site | Knoxville | Tennessee |
United States | Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102 | Lake Worth | Florida |
United States | Novartis Investigative Site | Latham | New York |
United States | Novartis Investigative Site | Lexington | Kentucky |
United States | Torrance Clinical Research Institute, 25043 Narbonne Avenue | Lomita | California |
United States | Meridien Research, 2300 Maitland center, Pkwy Ste 230 | Maitland | Florida |
United States | Novartis Investigative Site | Melbourne | Florida |
United States | Novartis Investigative Site | Memphis | Tennessee |
United States | Advanced Clinical Research, 2950 E Magic View Dr, Suite 182 | Meridian | Idaho |
United States | Novartis Investigative Site | Merritt Island | Florida |
United States | Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112 | Miami | Florida |
United States | New Horizon Research Center, 11880 SW 40 St., Suite 405 | Miami | Florida |
United States | Novartis Investigative Site | Miami | Florida |
United States | Novartis Investigative Site | Miami | Florida |
United States | Novartis Investigative Site | Miami Beach | Florida |
United States | Novartis Investigative Site | Milwaukee | Wisconsin |
United States | Novartis Investigative Site | Nashville | Tennessee |
United States | Yale University, One Church Street, Suite 600 | New Haven | Connecticut |
United States | NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226 | New York | New York |
United States | Novartis Investigative Site | Oklahoma City | Oklahoma |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Orangeburg | New York |
United States | Compass Research, LLC,100 West Gore Street, Suite 202 | Orlando | Florida |
United States | Novartis Investigative Site | Orlando | Florida |
United States | Novartis Investigative Site | Ormond Beach | Florida |
United States | Novartis Investigative Site | Oxnard | California |
United States | Novartis Investigative Site | Palm Beach Gardens | Florida |
United States | Novartis Investigative Site | Palo Alto | California |
United States | Novartis Investigative Site | Philadelphia | Pennsylvania |
United States | Banner Alzheimer's Institute, 901 East Willetta Street | Phoenix | Arizona |
United States | Novartis Investigative Site | Port Orange | Florida |
United States | Novartis Investigative Site | Portland | Oregon |
United States | Summit Research Network, 2701 NW Vaughn St, Suite 350 | Portland | Oregon |
United States | Butler Hospital, 345 Blackstone Blvd. | Providence | Rhode Island |
United States | Novartis Investigative Site | Rochester | New York |
United States | Novartis Investigative Site | Rochester | Minnesota |
United States | Novartis Investigative Site | Saint Louis | Missouri |
United States | Novartis Investigative Site | San Antonio | Texas |
United States | Novartis Investigative Site | San Diego | California |
United States | Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130 | Santa Ana | California |
United States | Roskamp Institute, Inc., 2040 Whitfield Avenue | Sarasota | Florida |
United States | Novartis Investigative Site | Sebastopol | California |
United States | Novartis Investigative Site | Sherman Oaks | California |
United States | Novartis Investigative Site | Stamford | Connecticut |
United States | Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B | Sun City | Arizona |
United States | Novartis Investigative Site | Tacoma | Washington |
United States | Novartis Investigative Site | Tallahassee | Florida |
United States | Novartis Investigative Site | Tampa | Florida |
United States | Novartis Investigative Site | Tucson | Arizona |
United States | Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408 | Tulsa | Oklahoma |
United States | Novartis Investigative Site | Washington | District of Columbia |
United States | Novartis Investigative Site | West Long Branch | New Jersey |
United States | Novartis Investigative Site | West Palm Beach | Florida |
United States | Novartis Investigative Site | Wichita | Kansas |
United States | Novartis Investigative Site | Wichita | Kansas |
United States | Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100 | Willow Grove | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals | Amgen, Banner Alzheimer's Institute |
United States, Argentina, Australia, Belgium, Canada, Chile, China, Finland, France, Germany, Iceland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to last cognitive assessment performed (up to day 648) | |
Primary | 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. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | 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 | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | Change in the Total and Index 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. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | 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. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | Change in the Everyday Cognition Scale (ECog-Informant) 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. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | 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) and a general assessment of brain abnormalities. | Baseline up to study termination approximately 617 days | |
Secondary | 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. | Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | Change in CSF Levels of Amyloid Beta 40 (Aß40) | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aß40) | Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | Change in CSF Levels of Amyloid Beta 42 (Aß42) | Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aß42). | Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648) | |
Secondary | 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 Alzheimer's Disease-related biomarkers | Baseline to Months 24 and 60 | |
Secondary | Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer | To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers | Baseline to Months 24 and 60 | |
Secondary | Change in 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 | Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648) | |
Secondary | Change in Serum Neurofilaments | Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL) | Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648) | |
Secondary | 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. | Baseline up to study termination approximately 617 days |
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