The goal of this clinical trial is to learn whether home-based brain stimulation combined with virtual speech-language therapy can improve communication abilities in adults with logopenic variant primary progressive aphasia (lvPPA), a language disorder most often caused by Alzheimer's disease. The main questions the study aims to answer are: * Is combining remotely supervised transcranial direct current stimulation (tDCS) with virtual speech-language therapy feasible and acceptable for people with lvPPA? * Does this combined treatment lead to improvements in communication compared to speech-language therapy with sham (placebo) stimulation? * Do individual brain characteristics help predict who benefits most from this treatment? Researchers will compare participants who receive active tDCS plus virtual speech-language therapy to participants who receive sham (placebo) tDCS plus virtual speech-language therapy to see if active brain stimulation enhances communication outcomes. Participants will: * Complete speech-language therapy sessions delivered by video visit. * Receive either active or sham tDCS that is remotely supervised and completed at home. * Complete language and cognitive testing before and after treatment. * Undergo brain imaging and other assessments to help understand treatment response.
PhaseNA
TypeInterventional
Age40 Years
WhereSan Francisco, California, United States + 1 more
SponsorMaya Henry
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Trial on Agitation in Alzheimer's Dementia
NCT05543681 ·
Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden
RecruitingThe purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.
PhasePhase 2
TypeInterventional
Age60 Years
WhereMaitland, Florida, United States + 30 more
SponsorIGC Pharma, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
NCT06563895 · Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis
RecruitingTransthyretin amyloidosis (ATTR) is a disease where the normally occurring transthyretin (TTR) protein falls apart and forms amyloid, a sticky plaque-like substance that accumulates in different organs in the body and can cause damage to the organ. There are two ways that the TTR protein can fall apart. One way occurs as a person ages, where the normal TTR protein can fall apart and form amyloid that may no longer be sufficiently cleared by the body. This type of ATTR is known as wild-type ATTR (ATTRwt). The other way occurs when a person inherits a defective TTR gene that causes the TTR protein to spontaneously fall apart. This form of the disease is known as variant ATTR (ATTRv) and can be detected in adults by a genetic test of their TTR gene before they age. Amyloid build-up in the heart causes the heart wall to become thick and stiff and can result in heart failure and even death. Accumulation of TTR amyloid in the heart is known as transthyretin amyloid cardiomyopathy or ATTR-CM. Amyloid can also deposit in the nerve tissues leading to nerve problems. Accumulation of TTR in the nerves is known as transthyretin amyloid polyneuropathy or ATTR-PN. Acoramidis is an experimental drug designed to bind tightly to TTR in the blood and stabilize its structure, so it does not form the harmful amyloid plaques that can cause damage to organs. This study is intended to determine if treatment with acoramidis in participants with ATTRv who have not yet developed any symptoms of disease can prevent or delay the development of ATTR-CM or ATTR-PN disease. If adults with an inherited defective TTR gene are treated early before any of the symptoms of disease have developed, it may be possible to delay the onset or prevent the disease entirely.
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereLa Jolla, California, United States + 100 more
SponsorEidos Therapeutics, a BridgeBio company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia
NCT05741853 · Primary Progressive Aphasia, Dementia, Dementia, Frontotemporal
RecruitingDifficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA. The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.
PhaseNA
TypeInterventional
Age40 Years
WhereAustin, Texas, United States + 2 more
SponsorUniversity of Texas at Austin
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
RecruitingResearchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it
PhasePhase 2
TypeInterventional
Age50 Years – 85 Years
WhereIrvine, California, United States + 77 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
RecruitingThe purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).
PhasePhase 3
TypeInterventional
Age50 Years – 90 Years
WherePhoenix, Arizona, United States + 149 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
RecruitingNighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.
PhasePhase 4
TypeInterventional
Age55 Years
WhereAustin, Texas, United States
SponsorUniversity of Texas at Austin
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
RecruitingThe purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
PhasePhase 3
TypeInterventional
Age60 Years – 85 Years
WhereFullerton, California, United States + 123 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia
NCT06511752 ·
Alzheimer Disease, Dementia, Primary Progressive Aphasia
RecruitingThe current study aims to examine the benefits of an education/support group program for individuals with progressive aphasia (caused by various etiologies, diagnoses) and their carepartners. The current study utilizes pre-, post-treatment, and follow-up assessments to measure effects of a psychoeducational support group and an implementation/communication skills training phase on measures of psychosocial function, communicative effectiveness and speech/language function. Analysis of study-specific surveys and semi-structured interviews will provide qualitative data regarding outcomes. Before beginning the education and support group, focus groups will be run in order to set priorities for the themes to be included in the education program. Participants will join via tele-based means if preferred and these participants may reside in the United States, or internationally including Mexico and Spain.
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years
WhereAustin, Texas, United States
SponsorUniversity of Texas at Austin
▾Tap for detailsClick for full details — eligibility, all locations, contacts Paper-Based and Smartphone-Based Memory Supports
NCT06444841 ·
Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
RecruitingAlzheimer's disease and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training, but these approaches resulted in modest gains in clinical populations. By contrast, a Stage I pilot trial indicated that smartphone-based memory aids (reminder apps) can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance. The investigators will now test for efficacy, durability, and generalizability of benefits across diverse samples in a Stage II randomized controlled trial. Some 200 participants with mild cognitive impairment or mild dementia will be recruited, half of whom will be from digitally-disadvantaged backgrounds (low socioeconomic status, rural, or historically underrepresented groups). Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system. Across a 4-week intervention period, participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the intervention/control system. Durability of effects will be assessed at 3-month and 6-month follow-up sessions. As a secondary aim, study partners will be simultaneously enrolled to collect informant ratings, track how much study partners assist the participants, and determine whether improving prospective memory in patients improves quality of life in study partners (e.g., by reducing the double to-do list burden of remembering for themselves and for care recipients). As a third aim, the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research.
PhaseNA
TypeInterventional
Age50 Years
WhereAustin, Texas, United States + 2 more
SponsorBaylor University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
RecruitingThe purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
PhasePhase 3
TypeInterventional
Age55 Years – 90 Years
WhereChandler, Arizona, United States + 288 more
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
NCT06808984 · Agitation,
Alzheimer Disease RecruitingThis 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.
PhasePhase 2
TypeInterventional
Age55 Years – 90 Years
WhereHomewood, Alabama, United States + 52 more
SponsorCelgene
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