The LUCINDA Trial: LUpron 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 : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Placebo Drug: LUPRON DEPOT 22.5 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The LUCINDA Trial: LUpron 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
1.5 cc of 0.9% Sterile Sodium Chloride Injection, USP, administered with a 12 cc single-use syringe with a 21-gauge needle.
Placebo injections will consist of 1.5 cc of 0.9% Sterile Sodium Chloride Injection, USP, administered with a 12 cc single-use syringe with a 21-gauge needle.
Lupron 22.5mg intramuscularly / 3 months
Drug: LUPRON DEPOT 22.5 mg
LUPRON DEPOT 22.5 mg (or placebo) will be administered intramuscularly, in accord with manufacturer's direction, once every twelve weeks for 48 weeks.
- Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: Baseline, 48 Weeks ]The 13-item (ADAS-Cog-13) scoring ranges from 0 to 85, increasing with the severity of dementia.
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: Tom Maloney, PhDfirstname.lastname@example.org|
|United States, New York|
|Weill Medical College of Cornell University||Not yet recruiting|
|New York, New York, United States, 10021|
|Contact: Tom Maloney, PhD 646-962-8502 email@example.com|
|Principal Investigator: Tracy A Butler, MD|
|Principal Investigator:||Tracy A Butler, MD||Weill Medical College of Cornell University|