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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03131453
Other study ID # CCNP520A2202J
Secondary ID 2016-002976-28
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date August 3, 2017
Est. completion date March 26, 2020

Study information

Verified date August 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired participants aged 60 to 75 years, with at least one apolipoprotein E allele (APOE4), (homozygotes (HMs) or heterozygotes (HTs)) and, if HTs, with evidence of elevated brain amyloid. The participants were randomized to either CNP520 50 mg, CNP520 15 mg or placebo a 2:1:2 ratio and was stratified based on amyloid status. The planned treatment period of 5 to 8 years was not achieved due to early study termination.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CNP520 50mg
50 mg capsule
CNP520 15mg
15 mg capsule
Other:
Matching placebo
Matching placebo for 15 and 50 mg capsules

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Novartis Pharmaceuticals Amgen, Banner Alzheimer's Institute

Countries where clinical trial is conducted

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, 

Outcome

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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