Alzheimer's Disease Clinical Trial
— ExpeditionPROOfficial title:
A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease
| Verified date | September 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).
| Status | Terminated |
| Enrollment | 26 |
| Est. completion date | May 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria. - Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening. - Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening. - Scores =4 on Modified Hachinski Ischemia Scale (MHIS). - Scores >0 on the Functional Activities Questionnaire (FAQ). - Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology. Exclusion Criteria: - Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD. - Has known allergy to humanized monoclonal antibodies. - Has an ongoing clinically significant laboratory abnormality, as determined by the investigator. - Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E. - Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI. - Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Gatineau | |
| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Greenfield Park | |
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| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Kentville | |
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| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Ottawa | |
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| Finland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kuopio | |
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| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Roma | |
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| Puerto Rico | Santa Cruz Behavioral PSC | Bayamón | |
| Puerto Rico | Cortex, PSC | Las Piedras | |
| Puerto Rico | University Of Puerto Rico | Rio Piedras | |
| Puerto Rico | Instituto de Neurologia Dra. Ivonne Fraga | San Juan | |
| Puerto Rico | Latin Clinical Trial Center | San Juan | |
| Puerto Rico | SomniCare Sleep Institute | San Juan | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | |
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| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Castellon de la Plana | |
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| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | |
| Sweden | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Malmö | |
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| Taiwan | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taipei | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bath | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chelsea | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guildford | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Manchester | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Scotland | |
| United States | Abington Neurological Associates | Abington | Pennsylvania |
| United States | Albany Medical College | Albany | New York |
| United States | Lehigh Center for Clinical Research | Allentown | Pennsylvania |
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | Atlanta Center of Medical Research | Atlanta | Georgia |
| United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
| United States | PharmaSite Research Inc | Baltimore | Maryland |
| United States | Sheppard Pratt Health System | Baltimore | Maryland |
| United States | Sheppard Pratt Health System | Baltimore | Maryland |
| United States | The Memory Clinic | Bennington | Vermont |
| United States | ClinVest | Bolivar | Missouri |
| United States | Christie Clinic, LLC | Champaign | Illinois |
| United States | Alzheimer's Memory Center | Charlotte | North Carolina |
| United States | Clinical Research Professionals | Chesterfield | Missouri |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | MCB Clinical Research Centers | Colorado Springs | Colorado |
| United States | Millenium Psychiatric Associates LLC | Creve Coeur | Missouri |
| United States | Baylor AT&T Memory Center | Dallas | Texas |
| United States | Baylor AT&T Memory Center | Dallas | Texas |
| United States | FutureSearch Trials | Dallas | Texas |
| United States | Neurology Diagnostics, Inc. | Dayton | Ohio |
| United States | Brain Matters Research | Delray Beach | Florida |
| United States | Mile High Research Center | Denver | Colorado |
| United States | Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island |
| United States | Memory Enhancement Center of America, Inc. | Eatontown | New Jersey |
| United States | Alexian Brothers Medical Center | Elk Grove Village | Illinois |
| United States | QUEST Research Institute | Farmington Hills | Michigan |
| United States | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida |
| United States | Fort Wayne Neurological Center | Fort Wayne | Indiana |
| United States | United Osteoporosis Center | Gainesville | Georgia |
| United States | Parexel Early Phase Unit at Glendale | Glendale | California |
| United States | Hattiesburg Clinic | Hattiesburg | Mississippi |
| United States | Sunrise Clinical Research | Hollywood | Florida |
| United States | Houston Methodist | Houston | Texas |
| United States | University of Texas Health Services Center - Houston | Houston | Texas |
| United States | Metrolina Neurological Research Institute | Indian Land | South Carolina |
| United States | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | Josephson Wallack Munshower Neurology | Indianapolis | Indiana |
| United States | Clinical Neuroscience Solutions Inc | Jacksonville | Florida |
| United States | Clinical Trial Center, LLC, Psychiatry | Jenkintown | Pennsylvania |
| United States | St Lukes Hospital | Kansas City | Missouri |
| United States | Evergreen Professional Plaza | Kirkland | Washington |
| United States | Lake Charles Clinical Trials | Lake Charles | Louisiana |
| United States | Las Vegas Medical Research | Las Vegas | Nevada |
| United States | Baptist Health Medical Group | Lexington | Kentucky |
| United States | ActivMed Practices & Research, Inc | Methuen | Massachusetts |
| United States | Miami Jewish Health Systems | Miami | Florida |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | Dean Foundation for Health Research and Education | Middleton | Wisconsin |
| United States | Pyramid Clinical Research | Monroe | New Jersey |
| United States | Healthy Perspectives Innovative Mental Health Services, PL | Nashua | New Hampshire |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Suncoast Clinical Research | New Port Richey | Florida |
| United States | Christiana Care Research Institute | Newark | Delaware |
| United States | Sentara Medical Group | Norfolk | Virginia |
| United States | Sensible Healthcare | Ocoee | Florida |
| United States | Compass Research | Orlando | Florida |
| United States | Pacific Neuroscience Medical Group | Oxnard | California |
| United States | Pensacola Research Consultants, Inc. | Pensacola | Florida |
| United States | Banner Alzheimer's Institute | Phoenix | Arizona |
| United States | St Josephs Hospital and Medical Center | Phoenix | Arizona |
| United States | Xenoscience | Phoenix | Arizona |
| United States | Northeastern Pennsylvania Memory & Alzheimer's Center | Plains | Pennsylvania |
| United States | Donald S Marks | Plymouth | Massachusetts |
| United States | Quantum Laboratories | Pompano Beach | Florida |
| United States | Center for Cognitive Health | Portland | Oregon |
| United States | Summit Research Network Inc | Portland | Oregon |
| United States | ActivMed Practices & Research, Inc | Portsmouth | New Hampshire |
| United States | Princeton Medical Institute | Princeton | New Jersey |
| United States | Butler Hospital | Providence | Rhode Island |
| United States | Desert Valley Research | Rancho Mirage | California |
| United States | National Clinical Research - Richmond | Richmond | Virginia |
| United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | Univ of Texas Health Science Center at San Antonio | San Antonio | Texas |
| United States | Pacific Research Network Inc | San Diego | California |
| United States | Sharp Mesa Vista Hospital | San Diego | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Apex Research Institute | Santa Ana | California |
| United States | Care Access Research LLC | Santa Clarita | California |
| United States | Roskamp Institute | Sarasota | Florida |
| United States | Maine Neurology | Scarborough | Maine |
| United States | Insight Clinical Trials | Shaker Heights | Ohio |
| United States | California Neuroscience Research | Sherman Oaks | California |
| United States | The Cognitive and Research Center of NJ | Springfield | New Jersey |
| United States | New England Institute for Clinical Research | Stamford | Connecticut |
| United States | Richmond Behavorial Associates | Staten Island | New York |
| United States | Banner Sun Health Research Institute | Sun City | Arizona |
| United States | Axiom Research | Tampa | Florida |
| United States | Advanced Memory Research Institute of New Jersey | Toms River | New Jersey |
| United States | Bio Behavioral Health | Toms River | New Jersey |
| United States | Cotton O'Neil Clinic | Topeka | Kansas |
| United States | Arizona Health Sciences Center | Tucson | Arizona |
| United States | Center for Neurosciences | Tucson | Arizona |
| United States | Care Access Research | Valencia | California |
| United States | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida |
| United States | Heartland Research Associates | Wichita | Kansas |
| United States | Central DuPage Hospital | Winfield | Illinois |
| United States | Piedmont Medical Research | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Canada, Finland, France, Germany, Italy, Japan, Poland, Puerto Rico, Spain, Sweden, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score | ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity. | Baseline, 24 Months | |
| Secondary | Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) | The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Mini Mental Status Examination (MMSE) | MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Montreal Cognitive Assessment (MoCA) | The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Functional Activities Questionnaire (FAQ) | FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Neuropsychiatric Inventory (NPI) | The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) | CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT) | The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite) | RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D) | EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. | Baseline, 24 Months | |
| Secondary | Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD) | QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. | Baseline, 24 Months | |
| Secondary | Change From Baseline in Concentration of Plasma Amyloid-ß Peptide (Aß) and Plasma Solanezumab | Concentration of amino acid peptide known as Aß 1-42 in plasma. | Baseline, 24 Months | |
| Secondary | Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) | MRI will be used to assess the effect of treatment on rate of whole brain volume. | Baseline, 24 Months | |
| Secondary | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr) | Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio. | Baseline, 24 Months | |
| Secondary | Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aß and CSF Tau Proteins | Changes in CSF parameters, including total and free Aß1-40 and Aß1-42 species and total tau and P-tau181 peptides, will be assessed. | Baseline, 24 Months | |
| Secondary | Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET | Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology. | Baseline, 24 Months |
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