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98 Alzheimer's Disease Trials near Boston, MA
Power is an online platform that helps thousands of Alzheimer's Disease patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerSensory Stimulation for Alzheimer's Disease
Newton, Massachusetts
This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.
Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:50 - 92
Key Eligibility Criteria
Disqualifiers:Insufficient Adherence, Continuous Care, Others
Must Not Be Taking:Immunomodulators, Memantine, Nootropics
402 Participants Needed
Long-Term Safety of Simufilam for Alzheimer's Disease
Waltham, Massachusetts
The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:51 - 89
Key Eligibility Criteria
Disqualifiers:Not Listed
1081 Participants Needed
THC-Based Medication for Agitation in Alzheimer's
Amherst, New York
This trial tests a natural THC-based medicine called IGC-AD1, given in small doses regularly. It targets people aged 60 and above with Alzheimer's-related dementia who have been experiencing agitation. The THC in the medicine helps reduce agitation by interacting with brain signals. The most recent trial reported significant improvement in agitation using nabilone.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:60+
Key Eligibility Criteria
Disqualifiers:Seizures, Schizophrenia, Bipolar, Uncontrolled Hypertension, Others
164 Participants Needed
The BRAIN App for Dementia
Winchester, Massachusetts
There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050. There are about 46,000 long-term care (LTC) facilities in the U.S. More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable theme. While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials. One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence.
The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Non-verbal, Visual/hearing Impairments, Others
120 Participants Needed
Music Therapy for Dementia
Winchester, Massachusetts
Healthcare systems around the world, including within the United States, have long-established shortages of trained caregivers. The American Health Care Association states that "the health care system has experienced a shortage of trained caregivers for critical roles for some time." This scarcity directly impacts the 45,800 Long-Term Care (LTC) communities throughout the U.S.
Concurrent with this staff shortage, more than half of LTC residents have some form of dementia. These two issues create a serious public health concern, since dementia is associated with a variety of behavioral expressions, such as aggression, anxiety, and agitation. Behavioral expressions of dementia can be successfully managed with the use of tailored, psychosocial interventions and communication support. Unfortunately, existing staff shortages make the facilitation of such interventions challenging.
One powerful and often-overlooked approach to ameliorating staffing shortages involves the utilization of retired volunteers to facilitate interventions for persons with dementia (PWD). Based on the nearly universal love of music and a promising pilot study, the product to be developed and tested in this STTR will build upon the combined prior work of the Principal Investigators. Making Connections Thru Music (MCTM), an urgently needed product, will enable retired volunteers to facilitate an evidence-based music and discussion intervention with PWD. MCTM aims to improve engagement, enhance quality of life, and reduce behavioral expressions in PWD. The intervention will consist of two main components: (1) a comprehensive online training course for volunteers, which will provide a general overview of dementia, demonstrate effective communication strategies to use with PWD, and instruct volunteers to effectively facilitate MCTM sessions, and (2) an app containing a structured MCTM intervention protocol and toolkit, which will be the means by which volunteers facilitate MCTM. MCTM will be marketed to LTC communities.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Dementia, Cognitive Impairment, Rapid Decline
196 Participants Needed
Nicotinamide Riboside for Alzheimer's Disease
Belmont, Massachusetts
This trial is testing nicotinamide riboside (NR), a form of vitamin B3, to see if it can help people with early memory problems or mild Alzheimer's. The idea is that NR can boost a molecule called NAD+ in the brain, which helps cells produce energy and reduces stress. Researchers hope this will improve brain function in these patients. Nicotinamide riboside (NR) is a precursor to NAD+ and has shown potential in improving learning and memory in animal models of dementia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:55 - 89
Key Eligibility Criteria
Disqualifiers:Psychotic Disorder, Stroke, Cancer, Others
Must Not Be Taking:Benzodiazepines, Barbiturates, Opiates, Others
50 Participants Needed
Allopregnanolone for Alzheimer's Disease
Waltham, Massachusetts
A phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Allopregnanolone as a regenerative therapeutic for Alzheimer's disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55 - 80
Key Eligibility Criteria
Disqualifiers:Stroke, Seizure Disorder, Malignant Disease, Others
Must Not Be Taking:Benzodiazepines, Anticonvulsants, Antipsychotics, Others
200 Participants Needed
Donanemab for Early Alzheimer's Disease
Watertown, Massachusetts
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
Key Eligibility Criteria
Disqualifiers:Neurological Disease, Serious Illnesses, Cancer, Others
Must Not Be Taking:Anti-amyloid Immunotherapy
1175 Participants Needed
Care Coordination Program for Dementia
Watertown, Massachusetts
This is a randomized, pragmatic clinical trial to evaluate the effectiveness of a collaborative care-coordination program embedded in a health plan for people living with Alzheimer's disease and related dementias (ADRD) and their care partners versus usual care. The study population will include community-dwelling Medicare Advantage members living with ADRD and their care partners. Outcomes will be healthcare utilization outcomes of individuals with ADRD and include emergency department visits, outpatient visits, avoidable emergency department visits, and admission to long-term care facilities.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Nursing Home, Hospice, Dementia Care Program
2160 Participants Needed
Escitalopram for Agitation in Alzheimer's Disease
Quincy, Massachusetts
The purpose of this study is to evaluate the safety and efficacy of escitalopram for agitation in Alzheimer's dementia.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Not Listed
187 Participants Needed
ECT for Dementia
Belmont, Massachusetts
This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability/safety outcomes of ECT+UC.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40+
Key Eligibility Criteria
Disqualifiers:Delirium, Stroke, Schizophrenia, Bipolar, Others
50 Participants Needed
AVP-786 for Agitation in Alzheimer's Disease
Braintree, Massachusetts
This trial is testing a medication called AVP-786 on individuals who have taken part in previous studies. The goal is to see if this medication can help with their conditions over time.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:50 - 90
Key Eligibility Criteria
Disqualifiers:Not Listed
1197 Participants Needed
Buntanetap for Alzheimer's Disease
Foxborough, Massachusetts
The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Major Depression, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
760 Participants Needed
Semaglutide for Early Alzheimer's Disease
Methuen, Massachusetts
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.
Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.
The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.
Participants must have a study partner, who is willing to take part in the study.
Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.
A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Parkinson's, Schizophrenia, Bipolar, Others
Must Be Taking:Alzheimer's Treatments
1840 Participants Needed
VHB937 for Alzheimer's Disease
Methuen, Massachusetts
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early AD followed by an Extension. The double-blind part is 72 weeks long, followed by an extension.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Non-AD Dementia, Cardiac Conditions, Stroke, Cancer, Others
Must Be Taking:AChEIs, Memantine
407 Participants Needed
Mevidalen for Alzheimer's Disease
Methuen, Massachusetts
The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. This is done by looking at participants: thinking and memory (cognition), everyday activities and sleep, AD symptoms, physical activity, irritability or anxiety. The study is expected to last approximately 26 weeks and may include up to 14 visits.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 80
Key Eligibility Criteria
Disqualifiers:Childbearing Potential, CNS Disease, Others
Must Not Be Taking:CYP3A4 Inhibitors, Inducers
300 Participants Needed
Semaglutide for Early Alzheimer's Disease
Methuen, Massachusetts
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.
Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.
The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.
Participants must have a study partner, who is willing to take part in the study.
Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.
A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Parkinson's, Schizophrenia, Bipolar, Others
Must Be Taking:Alzheimer's Treatments
1840 Participants Needed
ALZ-801 for Early Alzheimer's Disease
Plymouth, Massachusetts
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Moderate-severe ARIA, Others
Must Not Be Taking:Amyloid Antibodies
163 Participants Needed
PMN310 for Alzheimer's Disease
Plymouth, Massachusetts
This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:50+
Key Eligibility Criteria
Disqualifiers:Parkinson's, Huntington's, Stroke, Others
Must Be Taking:Acetylcholinesterase Inhibitors, Memantine
128 Participants Needed
Nicotine Patch for Mild Cognitive Impairment
Plymouth, Massachusetts
The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with MCI. Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function.
The study will enroll 380 participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Tobacco Use, Neurologic Disease, Major Depression, Others
Must Be Taking:Memantine, Cholinesterase Inhibitors
380 Participants Needed
Why Other Patients Applied
"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'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 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
"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
Piromelatine for Alzheimer's Disease
Island Park, Rhode Island
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
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Cardiovascular, Others
Must Be Taking:Acetylcholinesterase Inhibitors, Memantine
225 Participants Needed
KarXT + KarX-EC for Agitation in Alzheimer's Disease
Worcester, Massachusetts
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Urinary Retention, Others
Must Not Be Taking:MAO Inhibitors, Anticonvulsants, Mood Stabilizers, Tricyclics
352 Participants Needed
KarXT + KarX-EC for Alzheimer's Disease
Worcester, Massachusetts
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Pulmonary, Renal, Others
600 Participants Needed
Xanamem for Alzheimer's Disease
East Providence, Rhode Island
Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).
This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50+
Key Eligibility Criteria
Disqualifiers:Non-AD Dementia, Major Mental Illness, Diabetes, Others
Must Be Taking:Symptomatic AD Medications
220 Participants Needed
BMS-986368 for Alzheimer's Disease
East Providence, Rhode Island
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Schizoaffective, Others
120 Participants Needed
JNJ-64042056 for Alzheimer's Disease
Providence, Rhode Island
The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55 - 75
Key Eligibility Criteria
Disqualifiers:Alzheimer's Dementia, Mild Cognitive Impairment, Others
498 Participants Needed
ABBV-916 for Early Alzheimer's Disease
Providence, Rhode Island
This trial is testing a new drug called ABBV-916 to see if it can help people aged 50-90 who are in the early stages of Alzheimer's disease. Participants will receive the drug regularly over several months. The study aims to find out if the drug is safe and effective by monitoring changes in symptoms and side effects.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 90
Key Eligibility Criteria
Disqualifiers:Vasogenic Edema, Microhemorrhages, Others
Must Not Be Taking:Anticoagulants
106 Participants Needed
Emtricitabine for Alzheimer's Disease
Providence, Rhode Island
This is a randomized, double-blind clinical trial of a daily oral dose of 200 mg emtricitabine vs. placebo in 35 participants with biomarker-confirmed MCI or mild to moderate dementia due to Alzheimer's disease. Study duration for each subject participating in the placebo-controlled research study will be approximately 12 months (up to a 3 months Screening Period, Baseline visit (1 month), 6 months of placebo or emtricitabine dosing, and 1 month follow-up). Participants will have up to 2 months to complete all procedures for the month 6 study visit.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Parkinson's, Schizophrenia, Bipolar, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
35 Participants Needed
Educational Program for Alzheimer's Disease
Worcester, Massachusetts
Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Nursing Home, Palliative Care, Others
Must Be Taking:Alzheimer's Medications
11375 Participants Needed
Health Education for Alzheimer's Disease Prevention
Providence, Rhode Island
Modifying health behaviors like physical activity level, diet, stress, and mental activity level can lower risk for Alzheimer's disease, but many middle-aged and older adults find it difficult to sustain health behavior changes over the long term. This project will develop a new intervention that educates people about Alzheimer's disease risk factors and helps them understand how their personal health beliefs may prevent them from making long-lasting lifestyle changes. The goal is to help people sustain health behavior changes to prevent or delay the onset of Alzheimer's disease and related dementias.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:45 - 69
Key Eligibility Criteria
Disqualifiers:Not Listed
40 Participants Needed
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