With this failure your doctor and hospital will need to pursue other options. You absolutely need a treatment for dementia/Alzheimers. Don't let your hospital do nothing.
Your chances of getting dementia.
1. A documented 33% dementia chance post-stroke from an Australian study? May 2012.
2. Then this study came out and seems to have a range from 17-66%. December 2013.
3. A 20% chance in this research. July 2013.
4. Dementia Risk Doubled in Patients Following Stroke September 2018
5. Parkinson’s Disease May Have Link to Stroke March 2017
The latest here:
Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer DiseaseThe AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials
Alette M. Wessels, PhD1; Pierre N. Tariot, MD2; Jennifer A. Zimmer, MD1; et al
Katherine J. Selzler, PhD1; Sonja M. Bragg, MPH1; Scott W. Andersen, MS1; John Landry, MMath1; James H. Krull, PharmD1; AnnCatherine M. Downing, PharmD1; Brian A. Willis, PhD1; Sergey Shcherbinin, PhD1; Jamie Mullen, MD3,4; Peter Barker, PhD3; Jennifer Schumi, PhD3; Craig Shering, DPhil3; Brandy R. Matthews, MD1; Robert A. Stern, PhD5; Bruno Vellas, MD6; Sharon Cohen, MD7; Emer MacSweeney, FRCR8; Mercè Boada, MD9,10; John R. Sims, MD1
JAMA Neurol. 2020;77(2):199-209. doi:10.1001/jamaneurol.2019.3988
Key PointsQuestion
Does lanabecestat, a potent inhibitor of the beta-site amyloid
precursor protein–cleaving enzyme 1 (BACE1), slow the progression of
early Alzheimer disease (AD) and mild AD dementia?
Findings In 2 global randomized clinical trials (AMARANTH [n = 2218] and DAYBREAK-ALZ [n = 1722]), daily lanabecestat at both doses tested (20 mg and 50 mg) failed to slow cognitive or functional decline compared with placebo.
Meaning In patients with early AD or mild AD dementia, lanabecestat was generally well tolerated but did not slow cognitive or functional decline.
Importance
Alzheimer disease (AD) is a neurodegenerative disorder
characterized by cognitive deterioration and impaired activities of
daily living. Current treatments provide only minor symptomatic
improvements with limited benefit duration. Lanabecestat, a
brain-permeable inhibitor of human beta-site amyloid precursor
protein–cleaving enzyme 1 (BACE1/β-secretase), was developed to modify
the clinical course of AD by slowing disease progression.
Objective To assess whether lanabecestat slows the progression of AD compared with placebo in patients with early AD (mild cognitive impairment) and mild AD dementia.
Design, Setting, and Participants AMARANTH (first patient visit on September 30, 2014; last patient visit on October 4, 2018) and DAYBREAK-ALZ (first patient visit on July 1, 2016; last patient visit on September 28, 2018) were randomized, placebo-controlled, phase 2/3 and phase 3 clinical trials lasting 104 weeks and 78 weeks, respectively. AMARANTH and DAYBREAK-ALZ were multicenter, global, double-blind studies conducted at 257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively. A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging–Alzheimer’s Association criteria for early AD or mild AD dementia was screened using cognitive assessments, and the presence of amyloid was confirmed. Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation. AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study. DAYBREAK-ALZ screened 5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study.
Interventions Patients were randomized (1:1:1) to once-daily oral doses of lanabecestat (20 mg), lanabecestat (50 mg), or placebo.
Main Outcomes and Measures The primary outcome measure was change from baseline on the 13-item Alzheimer Disease Assessment Scale–cognitive subscale. Secondary outcomes included Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory. Efficacy analyses were conducted on the intent-to-treat population.
Results Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women. Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women. Both studies were terminated early after futility analysis. There were no consistent, reproducible dose-related findings on primary or secondary efficacy measures. Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
Conclusions and Relevance Treatment with lanabecestat was well tolerated and did not slow cognitive or functional decline.
Trial Registration ClinicalTrials.gov identifiers: NCT02245737 and NCT02783573
Findings In 2 global randomized clinical trials (AMARANTH [n = 2218] and DAYBREAK-ALZ [n = 1722]), daily lanabecestat at both doses tested (20 mg and 50 mg) failed to slow cognitive or functional decline compared with placebo.
Meaning In patients with early AD or mild AD dementia, lanabecestat was generally well tolerated but did not slow cognitive or functional decline.
Abstract
Objective To assess whether lanabecestat slows the progression of AD compared with placebo in patients with early AD (mild cognitive impairment) and mild AD dementia.
Design, Setting, and Participants AMARANTH (first patient visit on September 30, 2014; last patient visit on October 4, 2018) and DAYBREAK-ALZ (first patient visit on July 1, 2016; last patient visit on September 28, 2018) were randomized, placebo-controlled, phase 2/3 and phase 3 clinical trials lasting 104 weeks and 78 weeks, respectively. AMARANTH and DAYBREAK-ALZ were multicenter, global, double-blind studies conducted at 257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively. A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging–Alzheimer’s Association criteria for early AD or mild AD dementia was screened using cognitive assessments, and the presence of amyloid was confirmed. Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation. AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study. DAYBREAK-ALZ screened 5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study.
Interventions Patients were randomized (1:1:1) to once-daily oral doses of lanabecestat (20 mg), lanabecestat (50 mg), or placebo.
Main Outcomes and Measures The primary outcome measure was change from baseline on the 13-item Alzheimer Disease Assessment Scale–cognitive subscale. Secondary outcomes included Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory. Efficacy analyses were conducted on the intent-to-treat population.
Results Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women. Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women. Both studies were terminated early after futility analysis. There were no consistent, reproducible dose-related findings on primary or secondary efficacy measures. Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
Conclusions and Relevance Treatment with lanabecestat was well tolerated and did not slow cognitive or functional decline.
Trial Registration ClinicalTrials.gov identifiers: NCT02245737 and NCT02783573
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