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Alzheimer Disease clinical trials

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NCT ID: NCT05466422 Recruiting - Alzheimer Disease Clinical Trials

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)

Start date: September 20, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment (MCI) or mild-to-moderate Alzheimer's Disease (AD). The primary hypothesis (Part 1) is that at a generally well tolerated dose level, the true geometric mean concentration at Day 85 of MK-2214 in cerebrospinal fluid is >0.3 nanomolar (nM). Optional healthy older participants (Part 2) may receive MK-2214 at dose levels determined by criteria met in Part 1.

NCT ID: NCT05464368 Recruiting - Alzheimer Disease Clinical Trials

R21 Roche: 3-Way Tau Tracers in AD

Start date: February 1, 2023
Phase: Phase 1
Study type: Interventional

This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and [18F]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in patients with Alzheimer disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these three next-generation TAU radioligands and compare each of them with historical data of the current most widely used first generation radioligand, 18F-AV1451. Upto38 (30 AD (Amyloid +)and 8 OC (Amyloid -), matched for age and sex with A+ subjects) male and female subjects aged 50-100 will be enrolled in this study protocol: up to 8 for Cohort 1, up to 8 for Cohort 2, and up to 22 for Cohort 3. The study consists of three cohorts: Cohort 1: Up to8 AD subjects (A+; CDR 0.5 and 1)will receive two PET scans in random order, with receiving either18F-RO948 or18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 2:Up to8 OC (A-; CDR=0)subjects will receive two PET scans in random order, with receiving either18F-RO948or 18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 3:Up to 22 (A+; CDR = 0, .5 and 1) subjects will receive three PET scans in random order, with receiving 18F-RO94818F-MK6240 or18F-GTP1at the first scan. Efforts will be made to include about 1/3 CDR = 0, 1/3 CDR .5, and 1/3 CDR 1 in Cohort 3.

NCT ID: NCT05463731 Recruiting - Alzheimer's Disease Clinical Trials

A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Start date: August 1, 2022
Phase: Phase 3
Study type: Interventional

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer's disease (AD).

NCT ID: NCT05462106 Recruiting - Alzheimer's Disease Clinical Trials

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)

Start date: June 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.

NCT ID: NCT05457998 Recruiting - Alzheimer Disease Clinical Trials

BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers

Start date: June 14, 2023
Phase:
Study type: Observational

This research study aims to examine biomarkers of Alzheimer's disease as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Memory and Aging Program at Butler Hospital. The study will enroll up to 200 cognitively healthy subjects aged 50 to 80 years with ongoing recruitment and enrollment for 2 years, and subject participation lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure. Two PET imaging sub-studies will also be optional.

NCT ID: NCT05456503 Recruiting - Alzheimer Disease Clinical Trials

PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using PI-2620

Start date: September 19, 2022
Phase: Phase 3
Study type: Interventional

The investigators will compare PI-2620 tau PET scans from patients with frontotemporal lobar degeneration (FTLD), patients with non-amnestic presentations of Alzheimer's disease (naAD), and demographically matched cognitively normal seniors.

NCT ID: NCT05453539 Recruiting - Alzheimer Disease Clinical Trials

Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease

Start date: November 9, 2022
Phase: Phase 1
Study type: Interventional

This study is a Phase 1, first-in-human, multi-center study to establish safety of ADx-001 in healthy volunteers, and safety and proof of concept in patients with confirmed amyloid plaques in the brain (confirmed by amyloid positron emission tomography (PET)). ADx-001 is a novel, intravenously delivered, Gd- containing molecularly targeted liposomal product that is being developed for use in contrast-enabled MR imaging of amyloid plaques.

NCT ID: NCT05452031 Recruiting - Sleep Clinical Trials

A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

Start date: November 9, 2022
Phase: N/A
Study type: Interventional

This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.

NCT ID: NCT05443308 Recruiting - Alzheimer Disease Clinical Trials

Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease

Start date: June 21, 2022
Phase:
Study type: Observational

Alzheimers disease and cerebral small vessel disease have a considerably overlap in patients and have common risk factors. The diseases are difficult to separate in individual patients and we hypothesize that a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease. Patients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative [15O]H2O positron emission tomography (PET) for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional [15O]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.

NCT ID: NCT05427448 Recruiting - Alzheimer Disease Clinical Trials

Validation of Blood Biomarkers for Alzheimer's Disease

ALZAN
Start date: November 24, 2022
Phase: N/A
Study type: Interventional

Alzheimer's disease (AD) has gradually become one of the major global public health issues due to its prevalence, which increases with age and life expectancy, and the economic cost of caring for patients whose cognitive decline progressively leads to loss of functional autonomy. The diagnosis of AD is based on a multidisciplinary approach, involving, among other things, evaluation of the medical history together with clinical symptoms and signs, neuropsychological tests and neuroimaging. The quantification of cerebrospinal fluid (CSF) core biomarkers (amyloid beta peptides [Ab1-40 and Ab1-42], total tau [t-tau] and its phosphorylated form on threonine 181 [p-tau(181)]) has progressively proven utility for the diagnosis of AD and its prodromal forms. CSF biomarkers are now included in international guidelines for the diagnosis of AD in research settings and clinical practice and the Alzheimer's Association appropriate use criteria for the use of lumbar puncture and CSF testing in the diagnosis of AD have been published. Such biochemical diagnostics are currently implemented in many specialized centers around the world. Recent progress in the biological diagnosis of AD is considerable, with the possibility, thanks to ultra-sensitive tests realized notably with the SIMOA technology, of having Ab1-40, Ab1-42, t-tau and p-tau(181) also detectable in the blood using commercial kits. The performance for AD detection has been evaluated by many groups including on retrospective samples. It is now essential to evaluate the interest of blood-based biomarkers of AD, prospectively and in real life condition to confront them with pre-analytical and analytical variabilities. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.