Alzheimer's Disease Clinical Trial
Official title:
Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no
cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid
(β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD
patients are required to have these amyloid plaques in the brain in order to have a
definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the
production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and
was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in
blood, spinal fluid and brain in animals tested thus far. This study used several different
tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some
patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture
of amyloid plaques in the brain. Other tests measured the overall function of the brain and
brain size in some patients. In this trial, patients who initially received placebo
(inactive sugar pill) were, at a certain point in the study, switched over to active drug,
semagacestat. In other words, all patients could eventually receive active drug. Each
patient's participation could last approximately 2 years. Patients taking approved AD
medications were permitted to participate in this study and continue taking these
medications during the study. All patients who completed this study had the option to
continue receiving semagacestat by participating in an open label study.
Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568])
showed semagacestat did not slow disease progression and was associated with worsening of
clinical measures of cognition and the ability to perform activities of daily living. Study
drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been
amended to continue collecting safety data, including cognitive scores, for at least seven
months. The CT-Registry will reflect results of analyses from the original protocol in
addition to those from the amended protocol.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
Withdrawn |
NCT03316898 -
A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease
|
Phase 1 | |
Withdrawn |
NCT02860065 -
CPC-201 Alzheimer's Disease Type Dementia: PET Study
|
Phase 2 | |
Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
Recruiting |
NCT05607615 -
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
|
Phase 2 | |
Terminated |
NCT03307993 -
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
|
Phase 1 | |
Recruiting |
NCT02912936 -
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
|
N/A | |
Active, not recruiting |
NCT02899091 -
Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease
|
Phase 1/Phase 2 | |
Completed |
NCT02907567 -
Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT02868905 -
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
|
N/A | |
Terminated |
NCT02521558 -
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
|
N/A | |
Completed |
NCT02580305 -
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
|
Phase 2 | |
Completed |
NCT02516046 -
18F-AV-1451 Autopsy Study
|
Phase 3 | |
Recruiting |
NCT02247180 -
Cognitive Rehabilitation in Alzheimer`s Disease
|
N/A | |
Completed |
NCT02260167 -
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
|
N/A | |
Completed |
NCT02317523 -
Alzheimer's Caregiver Coping: Mental and Physical Health
|
N/A | |
Terminated |
NCT02220738 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
|
Phase 1 | |
Completed |
NCT02256306 -
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
|
N/A | |
Completed |
NCT01826110 -
PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers
|
Phase 1 |