Dementia Paid Clinical Trials in Pennsylvania

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Read Less

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers. Read Less

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants. Read Less

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups. Read Less

The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Read Less

The overall aim of this study is to pilot test Promoting Positive Care Interactions (PPCI) with the goal of establishing a feasible and culturally responsive approach to optimize care interactions between staff (nursing, activity, housekeeping, and dining service staff) and residents with ADRD in assisted living facilities (ALFs), and further improve select resident, staff, and facility outcomes. PPCI is a non- pharmacological four-step approach consisting of (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions. Read Less

Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two escalating dose (low dose and medium dose) cohorts are planned, as well as one bridging cohort which will allocate patients to receive either low or medium dose. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884963 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes. Read Less

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond. Read Less

The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings. Read Less

This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B. Read Less

PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain. This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the granulin precursor (GRN) or chromosome 9 open reading frame 72 (C9ORF72) genes Read Less

The goal of this step-wedge trial is to test the implementation of daily nurse screening for delirium in routine care and its impact on outcomes and complications in hospitalized older adults admitted to 6 general medicine/surgery units at 3 hospitals in Pennsylvania and Massachusetts. The main question\[s\] it aims to answer are: * 1. To test the fidelity, accuracy, and sustainability of implementing daily nurse screening for delirium using the UB-CAM in routine care. * 2. To evaluate the impact of UB-CAM delirium screening on patient and care partner centered outcomes assessed at one month follow-up interviews 3. To evaluate the impact of UB-CAM screening on rates of delirium complications (falls, pressure injury, aspiration) and adverse delirium management (psychoactive medication use, restraint use). Participants (patients) will be assessed for delirium on study days 1, 2 and 3 (or until hospital discharge) and will be asked basic demographics. These patients will be contacted by phone 1 month after enrollment to collect information about inpatient facility use and to administer the Delirium Burden Patient Scale. Participants (care partners) will be interviewed at the patient's discharge to complete the Alzheimer's Disease-8 scale. These care partners will be contacted by phone 1 month after enrollment to complete the Delirium Burden Caregiver Scale and to complete a Qualitative Interview which includes questions about communication and collaboration. Read Less