Dementia

Newark, DE

83 Dementia Trials near Newark, DE

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

Decision Support for Dementia Caregivers

Washington, District of Columbia
The purpose of this study is to design and test a decision-making program that is tailored to support adult daughters making healthcare decisions for their parents who are living with memory loss to improve the quality of life of African American families. There are two phases of this research study. The first phase will collect information by surveys and/or interviews. The surveys and interviews will ask questions about demographics (e.g., age, race/ethnicity), culture, health, family dynamics, caregiving, and healthcare experiences. The surveys will be completed by all eligible adult daughters and parents with memory loss in pairs. The interviews will be completed by a smaller number of pairs and by all former adult daughter caregivers. The general scope of topics is caregiving experiences, cultural identity, healthcare decisions for persons living with Alzheimer's disease, and related dementias, health, and well-being. The research team will identify and examine key factors that will lead to designing and testing the feasibility of a culturally tailored prototype intervention for African American dementia dyads/families of persons living with mild to moderate Alzheimer's disease and related dementias.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

40 Participants Needed

Piromelatine for Alzheimer's Disease

Jersey City, New Jersey
This trial tests piromelatine, a pill taken before bed, in people with mild Alzheimer's who lack a specific genetic variation. The goal is to see if it can improve brain function and slow down dementia progression.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:60 - 85

225 Participants Needed

GSK4527226 for Early Alzheimer's Disease

Toms River, New Jersey
The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment \[MCI\] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 85

367 Participants Needed

GSK4527226 for Alzheimer's Disease

Toms River, New Jersey
The study medicine GSK4527226 is being studied in participants with Alzheimer's Disease (AD) in study 219867 (the parent study, NCT06079190). This new study is an extension of that parent study called an open-label extension (OLE). An OLE is a clinical trial where all participants receive the same study medicine. Participants must already be in study 219867 to be able to take part in this study. This study will assess the long-term safety and efficacy of GSK4527226 in participants with early AD (including mild cognitive impairment \[MCI\] and mild dementia due to AD) who have completed the parent study.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 85

297 Participants Needed

PET Imaging for Alzheimer's Disease

Bethesda, Maryland
Background: About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI. Objective: To test whether medical imaging using a new radiotracer (\[18F\]PF-06445974) can measure PDE4B in the brains of people with AD or MCI. Eligibility: People aged 50 years and older with AD or MCI. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits with 3 imaging scans of the brain. They will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory. Participants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each. Participants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Age:50 - 100

90 Participants Needed

AXS-05 for Alzheimer's Disease Agitation

Arlington, Virginia
The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:65 - 90

150 Participants Needed

Acamprosate for ALS

Bethesda, Maryland
Background: Amyotrophic lateral sclerosis (ALS) is a disorder that damages nerve cells in the brain and spinal cord. It can cause muscle weakness, paralysis, and loss of movement. The symptoms grow worse over time. Half of all people with ALS live only 3 to 5 years after diagnosis. Current drug treatments can slow the progress of the disease, but they cannot stop or reverse it. Objective: To test a study drug (acamprosate) in people with ALS with a mutation in the C9orf72 gene. Eligibility: People aged 18 years and older with ALS. They must have a mutation in the C9orf72 gene. Design: Participants will have 13 visits over 32 weeks. Five visits will be at the clinic, and 8 visits will be by phone. Participants will have a baseline visit of up to 3 days. They will have a physical exam with blood tests. They will have imaging scans and tests of their breathing ability. Their memory, thinking, and behavior will be assessed. They will have a neurologic exam to check their reflexes, strength, balance, eyes, and coordination. They will complete questionnaires about their daily life. They will have a lumbar puncture to collect fluid from the area around the spinal cord. Acamprosate is a pill taken by mouth. Participants will take 2 pills by mouth 3 times a day with meals for 24 weeks. They will record their doses and any missed doses in a diary. Baseline tests will be repeated during follow-up clinic visits. These tests may be spread out over 3 days. During phone visits, participants will talk about how they are doing. They will review their diary with researchers.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1

30 Participants Needed

EDITH-HC Training Tool for Dementia Care

New Brunswick, New Jersey
The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of a clinically useful, inclusive dementia-enhanced training and tool for use by home hospice clinicians to improve care and support for Black and White patients with dementia and their family caregivers. The investigators expect family caregivers of clinicians in the intervention group will report less caregiver burden (primary outcome) than caregivers of clinicians in the control group. The investigators expect that, compared to clinicians in the control group (usual care), clinicians in the intervention group (receive the training and use the tool) will demonstrate more knowledge of dementia-related caregiving issues (secondary outcomes). In exploratory analyses, the investigators expect family caregivers will report greater self-efficacy and preparedness, and that patients of clinicians in the intervention group will experience fewer live discharges than family caregivers of patients of clinicians in the control group.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 90

120 Participants Needed

Donanemab for Early Alzheimer's Disease

Fairfax, Virginia
This trial is testing different doses of donanemab, a drug aimed at helping people with early Alzheimer's disease. Donanemab has shown rapid reduction of brain amyloid in early Alzheimer's disease. The study will look at how often and how severely participants experience a side effect involving brain swelling. Researchers also want to find out which patient characteristics might predict this side effect.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60 - 85

1175 Participants Needed

PLAN Program for Dementia

Annandale, Virginia
Studies have shown that ethnic-racial minority elders are more likely to be neglected from appropriate dementia care in time than the white counterparts. Among minorities group, Korean Americans (KAs) are the 4th largest and one of the most rapidly growing Asian subpopulations and have been characterized as under-resourced and underserved population of dementia care. This research is being done to understand how an education and navigation support program led by trained community health workers (CHWs) helps Korean American elders with probable dementia and the Korean American elders' caregivers. In a 2-arm randomized controlled trial (RCT) with 288 dyads, the investigators' aims are to (1) test the effect of a community-based intervention delivered by trained CHWs for undiagnosed KA elders with probable dementia and the KA elders' caregivers, (2) evaluate the effect of the PLAN on improving caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life at 6 months in comparison to usual care, and (3) examine whether the effect of PLAN differs across age, sex, English proficiency and education caregiver subgroups. Exploratory Aim 1 is to test the effect of PLAN on Korean elders with probable dementia and caregiver development of a plan regarding dementia care at 6 months in comparison to usual care. The other two Exploratory Aims are to test the applicability of this study in another environment: Exploratory Aim 2: Using an equity-informed human-centered design framework, scale PLAN for implementation in ethnic daycare and Exploratory Aim 3: Pilot test the feasibility and acceptability of PLAN in ethnic adult daycare. Aim 1 and Exploratory Aim test the following hypotheses: (1) Korean elders with probable dementia who receive the PLAN will have higher rates of linkage to medical service for dementia than those in the control group (Aim 1) and (2) Korean elders with probable dementia and the KA elders' caregivers who receive the PLAN will have higher rates of having a plan for dementia care than those in the control group (Exploratory Aim). Aim 2 tests the following hypothesis: Caregivers in the PLAN group will have higher dementia literacy, self-efficacy in dementia care and service use, social support, and quality of life, and lower depression than those in the control group.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

288 Participants Needed

Suvecaltamide for Tremors in Parkinson's Disease

Fairfax, Virginia
This trial tests suvecaltamide, a medication aimed at reducing severe tremors in adults with Parkinson's disease whose current treatments are not effective. The medication likely helps by calming the overactive nerves or muscles responsible for the tremors.

Trial Details

Trial Status:Recruiting
Age:40 - 85

160 Participants Needed

Hearing Aid Intervention for Cognitive Decline

Hagerstown, Maryland
This trial is testing if giving hearing aids to older adults with untreated hearing loss can help slow down memory and thinking problems. It compares this to just giving general health advice. The idea is that better hearing keeps the brain active, which might help prevent cognitive decline. Hearing aids have been shown to improve cognitive function and offset declines in neural function in older adults.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:73 - 89

629 Participants Needed

Group Wellness Interventions for Neurologic Conditions

East Hanover, New Jersey
Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

360 Participants Needed

Remternetug for Alzheimer's Disease

New York, New York
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.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3

280 Participants Needed

Gantenerumab for Alzheimer's Disease

New York, New York
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.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3

280 Participants Needed

DECLARE Program for Dementia Caregivers

New York, New York
The goal of this clinical trial is to learn if the Dementia Caregivers' Link to Assistance and Resources (DECLARE) program can improve support of, and engagement with, caregivers of home health patients with dementia. DECLARE includes a caregiver self-assessment that is reported in the home health patient record, and increased access to social work for cases including dementia caregivers. The main questions we aim to answer are: * Will most caregivers who are offered the chance to complete an assessment choose to do so? * Will clinicians report that the assessment information was useful? * Will the rate of social work access increase for cases with patients with dementia who have involved family caregivers? Researchers will compare DECLARE to usual care to see if taking part in the program increases caregiver self-efficacy and access to social work. Participants will: * Answer a short series of assessment questions and questions about their caregiving experiences at the beginning of the home health episode. * Receive a social work visit from a Licensed Social Worker trained in dementia care. * Answer a series of follow-up questions about their caregiving experiences at the end of the home health episode.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

150 Participants Needed

Dementia and Nutrition Education for Alzheimer's Disease

New York, New York
These are the exploratory aims of the original trial cohort study "Old School Hip Hop RCT (AAAR5473)," which recruited 783 parents. 1. Continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study timeframe - aiming to understand participant knowledge and personal experiences with family members or friends affected by Alzheimer's Disease (AD). 2. Further examining the degree of comfort with dementia, as measured by a simplified version of the Dementia Attitudes Scale (DAS) focused on observable behaviors in children by their parents - aiming to understand the extent of stigmatization of dementia in communities served by this program, and if the trial impacted evidence of stigma. 3. Enrolling up to 75 parents who primarily spoke Spanish who were originally contacted in the RCT but were not eligible for completion of the original round of surveys given that all study materials were in English. This approach aims to better understand the impact of the program and Alzheimer disease on these families. Hypothesis 1: For the delayed follow-up with parents, the investigator anticipates that those with high dementia literacy or the largest dementia literacy improvement would sustain knowledge over 15-month period. Hypothesis 2: Children who received the intervention arm of the trial, who also have regular contact with a close friend or family member with dementia, will demonstrate positive dementia attitudes relative to students in the control arm. Hypothesis 3: Semi-structured interviews with Spanish speaking families will help program capacity to better serve the population and improve involvement in AD care and research.

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased

850 Participants Needed

Resilient Together Program for Dementia

New York, New York
This study will evaluate the feasibility and preliminary efficacy of the novel Resilient Together for Dementia (RT-D) intervention for couples following dementia diagnoses. The primary target is emotional distress, and the program aims to prevent chronic distress in at-risk couples.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

50 Participants Needed

OSA Treatment for Sleep Apnea

New York, New York
The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%\< 10/hour and AHI3A\<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:55 - 85

200 Participants Needed

Online Platform for Dementia Care

New York, New York
The purpose of this study is to evaluate an online platform -- the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) for persons with dementia and their family caregivers to engage in reminiscence activities together and record meaningful memories. The main aims of this study are: * To evaluate the feasibility and acceptability of the LMH-4-DCP platform. * To explore the potential for LMH-4-DCP to reduce feelings of pre-loss grief and enhancing relationship quality in dementia family caregivers and their care-recipients ('Care-Pairs') Care pair participants will be asked to log-in to LMH-4-DCP and complete study activities three times per week for two weeks. Researchers will compare the intervention group to an attention control condition to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

70 Participants Needed

Why Other Patients Applied

"I have a very strong family history of Alzheimer’s, with my maternal grandmother, mother, uncle, and sister having the disease. My APOE status is 2/4. My memory is going, although 6 months ago I tested decently on some cognitive tests. I'd like to help myself by getting ahead of my condition and help others in a similar situation by participating in medical research."

EK
Mild Cognitive Impairment PatientAge: 72

"I watched my mother die from Parkinson’s. At the time of her death, she weighed 85 pounds and could not move any muscles voluntarily except her eyelids. I would like to participate in a trial to help find a better treatment for PD than what is currently available. It is a devastating illness. It breaks my heart that other families will have to go through this."

WU
Healthy Volunteer PatientAge: 76

"I'm so used to losing things, forgetting things, making up to acronyms to remember things only to remember the acromym but not what the letters stand for... I enter a new room to look for an item, only to forget what I was looking for. I've discussed the existing treatments with my neurologist and she's on board with my joining a clinical trial."

AH
Dementia PatientAge: 64

"I watched my mother suffer through years of Alzheimer's Disease and I want to help advance the science for treating AD. I don't want anyone else to have go through what our family went through."

OF
Alzheimer's Disease PatientAge: 65

"I have been on standard Alzheimer's medication for a few years but know this treatment only works to delay my cognitive deterioration, not improve it. I've been doing research, which brought me here, to consider some of the latest research drugs. While I know that there's no guarantee that a clinical trial improves my condition, I'd like to give one a try and help further the research for all."

VL
Alzheimer's PatientAge: 71

Sleep, Cognition, and Pain Bundle for Delirium

New York, New York
Sleep disturbances, cognitive reserve, and continuing pain and inflammation are other risk factors contributing to delirium (confusion and agitation) and neurocognitive decline (in the long term) following heart surgery. Investigators aim to test a bundle of sleep optimization, cognitive exercise before surgery, and extended pain relief for 48 hours with intravenous acetaminophen combined with enhanced recovery after surgery protocols (SCOPE bundle). SCOPE will fill significant gaps in evidence by testing the value of a patient and care-provider-focused intervention that can potentially minimize POD and improve outcomes (cognitive \& physical function, sleep quality, pain, depression or anxiety, and survival) important to patients and families. The SCOPE trial will address many heart surgery outcome-related questions commonly asked by patients: What can I do to reduce my chances of developing confusion, hallucinations, or delirium after surgery? How can I best prepare before surgery to improve my long-term health and avoid disability? Are there exercises I can participate in that improve my sleep, pain, and mood after surgery? Intellectual pursuits, physical activity, and social interactions support cognitive reserve, while poor health, poor sleep hygiene, poor nutrition, and mental health disease can diminish reserve. Various interventions with different intensities and timing to augment cognitive reserve have been associated with positive outcomes on neuropsychological testing. Adaptive video gaming for as little as 10 hours leads to the maintenance of independence in activities of daily living and sustained improvements in speed of processing, attention, and working memory in older people. Likely through the increased cognitive reserve, perioperative brain exercise aims to protect against morbid cognitive recovery after surgery. Sleep is vital for memory and cognitive function. Poor sleep traits in older adults that are potentially modifiable, including short/long duration, daytime napping, and associated sleepiness, led to an almost 2-fold increase in delirium risk. Patients will complete an evidence-based course on healthy sleep habits and will complete guided exercises designed to restructure behaviors and thinking. They are encouraged to follow a set of recommendations to improve their sleep (e.g., optimal sleep duration, advice for habits such as daytime napping, maintaining a regular sleep schedule, avoiding caffeine, regular daylight exposure, dimming lights or electronics and relaxation and thought exercises for optimal sleep); many of these sleep behaviors have been strongly linked to increased risk for cognitive decline. Investigators propose that sleep optimization before AND after (an established best practice sleep bundle) surgical insult will contribute to cognitive reserve leading to decreased delirium risk and key patient-centered outcomes (postoperative sleep, pain, cognition, mood, and survival). Inadequate pain relief and opioids are both risk factors for delirium. Surgery on the chest is a significant pain source. Approximately 30-75% of patients suffer from moderate to severe pain in the postoperative period. Almost half of the patients have severe pain at rest, and three-quarters have severe pain during coughing and movement. Pain and inflammation are closely biochemically linked. Sleep, brain exercise, and adequate pain control with opioid-sparing can be additive or synergistic interventions to prevent delirium following heart surgery. Investigators propose three specific aims by conducting a 1:1 randomized controlled trial in 406 heart surgery patients 60 or older undergoing heart surgery. They will be administered perioperative sleep optimization, brain exercise training, and intravenous acetaminophen over 48 hours. A trained expert will administer the sleep and cognitive exercise protocols at least two weeks before surgery. This expert will handhold the patients for two weeks until the surgery. Thus, the gains made before surgery with better sleep quality and improved brain reserve will be sustained with postoperative pain control to lower the ongoing inflammation. Through this trial, investigators will evaluate if the SCOPE bundle can reduce 1) in-hospital delirium, 2) long-term (one, six, and twelve months) cognitive, physical, and self-care function, and 3) barriers to implementation of this bundle. Currently, no options are routinely available to patients to optimize their sleep and cognition before cardiac surgery. The proposed research is significant because it will be the first to test the bundled behavioral intervention approach (sleep optimization, brain exercise) before surgery with extended, scheduled pain management with non-opioids following surgery. The SCOPE trial will yield relevant and immediately actionable data to improve care for over 900,000 adults in the U.S. each year.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:60+

406 Participants Needed

SIRENS for Elder Abuse and Dementia

New York, New York
This research project has three main goals: (1) To create a new screening tool that helps primary care doctors spot signs of neglect in older adults with dementia. (2) To design a support program that can be delivered both in person and through a mobile app on Android phones. (3) To run a clinical trial with three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program-compared to standard care. This current phase of the project focuses on parts of goals 1 and 2, as described below.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:21+

40 Participants Needed

IV Acetaminophen for Delirium After Cardiac Surgery

New York, New York
Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+

900 Participants Needed

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