The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03649724|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : February 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild Cognitive Impairment||Drug: Placebo Drug: Eligard 22.5Mg Suspension for Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||February 2025|
|Estimated Study Completion Date :||February 2026|
Placebo Comparator: Placebo
0.25 ml of sterile normal saline administered subcutaneously / 12 weeks
Placebo (0.25 ml normal saline) will be administered subcutaneously once every twelve weeks for 48 weeks.
Eligard 22.5mg administered subcutaneously / 12 weeks
Drug: Eligard 22.5Mg Suspension for Injection
Eligard 22.5Mg Suspension for Injection will be administered subcutaneously, in accord with manufacturer's direction, once every twelve weeks for 48 weeks.
- Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog-11) [ Time Frame: Baseline, 48 Weeks ]The ADAS-cog-11 consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of Alzheimer's Disease.
- Percent change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, 48 Weeks ]The ADCS-ADL assesses a subject's ability to perform activities of daily living such as eating, walking and bathing.
- Alzheimer Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC+) [ Time Frame: Baseline, 48 Weeks ]The ADCS-CGIC+ uses structured interviews with the subject and his or her caregiver to determine whether there has been a change in the subject's overall level of functioning.
- Percent change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline, 48 Weeks ]The RBANS is a set of tests that measures thinking abilities including memory, language and attention.
- Percent change in Burden Inventory [ Time Frame: Baseline, 48 Weeks ]The Burden Inventory is a questionnaire that assesses how people sometimes feel when they are taking care of another person.
- Percent change in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 48 Weeks ]The NPI measures behavioral and emotional symptoms of Alzheimer's Disease.
- Change in Brain Magnetic Resonance Imaging (MRI) biomarkers [ Time Frame: Baseline, 48 Weeks ]Percent change in volume of AD-related brain regions (hippocampi, ventricles) and hippocampal perfusion measured with Arterial Spin Labeling (ASL) will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649724
|Contact: Patrick Harvey, MA||(646) firstname.lastname@example.org|
|Contact: Tom Maloney, PhDemail@example.com|
|United States, Florida|
|University of Miami Miller School of Medicine||Not yet recruiting|
|Palm Beach Gardens, Florida, United States, 33410|
|Contact: Olena Mahneva, PhD|
|Principal Investigator: James E Galvin, MD|
|United States, New York|
|Weill Medical College of Cornell University||Recruiting|
|New York, New York, United States, 10021|
|Contact: Patrick Harvey, MA 646-962-8508 firstname.lastname@example.org|
|Principal Investigator: Tracy A Butler, MD|
|United States, Wisconsin|
|University of Wisconsin - Madison||Not yet recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Rebecca Kintner 608-262-3456 email@example.com|
|Principal Investigator: Craig S Atwood, PhD|
|Principal Investigator:||Tracy A Butler, MD||Weill Medical College of Cornell University|
|Principal Investigator:||James E Galvin, MD||University of Miami|
|Principal Investigator:||Craig S Atwood, PhD||University of Wisconsin, Madison|