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Alzheimer Disease clinical trials

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NCT ID: NCT02347202 Completed - Dementia Clinical Trials

Tools for Distance Delivery of an Evidence-based AD Family Caregiver Intervention

Start date: October 2015
Phase: N/A
Study type: Interventional

A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). The NYU Caregiver Intervention (NYUCI) is an evidence-based intervention that provides counseling and support for families involved in the care of a relative or friend with Alzheimer's Disease and Related Dementias (ADRD). Most notably, the NYUCI substantially reduced caregiver's depressive symptoms, improved their physical health, and extended the time persons with ADRD remained at home by an average of 1.5 years (Mittelman et al., AG14634, formerly MH42216; See http://www.ncbi.nlm.nih.gov/pubmed/17101889). The intervention is now being widely implemented in-person, but there are barriers that prevent many caregivers from receiving its benefits, including geographic distance; impediments to older adults leaving their homes; and travel considerations for counselors which make it impossible to provide the NYUCI in person. The goal of this study is to evaluate the efficacy of an online videoconferencing version of the NYUCI. This innovative application has massive implications for social service delivery to older adults, because it will make it possible to deliver an in-person intervention, via the internet, which is already evidenced based to older adult caregivers who cannot currently be served. It will create the online reservation and management technology linking counselors with families as well as the evidence of effectiveness of providing such services via secure video teleconferencing vehicles. The proposed Telehealth Technology for Distance Counseling (TTDC) and related online educational training modules will connect skilled providers to the families of persons with dementia without regard to geographic location. Implications for rural healthcare delivery are particularly persuasive. To the investigators knowledge, this will be the first large-scale TTDC to be developed and rigorously tested with a randomized controlled trial. The investigators hypothesize that such a system, coupled with online training for providers and families on tele- counseling and distance caregiving, will have similar benefits to those achieved with in-person counseling during the original NYUCI RCT. This project includes an online reservation and management technology linking counselors with families via secure videoconferencing vehicles. The Telehealth Technology for Distance Counseling (TTDC), and online technology developed as part of this overall effort, will connect skilled providers to the families of persons with dementia without regard to geographic location. The related online clinical modules (i.e., interactive, computer-based educational materials) developed as a part of this grant effort will prepare counselors to provide the intervention, and caregivers to utilize the internet software, to be able to participate in counseling. The TTDC will include a scheduling system to link counselors to families at their mutual convenience and assure delivery in a cost-effective manner. The TTDC has the additional potential to transform ADRD care in ethnic and culturally diverse communities by connecting highly trained NYUCI counselors with specialized language and cultural skills to families who would not have access to these resources locally. In this study investigators will have 240 caregivers navigate the online educational module and the online reservation system for connecting caregivers with social workers. Half of the caregivers will then be paired with social service providers to receive counseling over the telephone, and the other half with be paired with social service providers to receive counseling via Zoom, a video conferencing program. Recruiting across the United States and Toronto, Canada.

NCT ID: NCT02346201 Completed - Alzheimer's Disease Clinical Trials

Apathy in Dementia Methylphenidate Trial 2

ADMET2
Start date: January 2016
Phase: Phase 3
Study type: Interventional

Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled, masked, 6 month, multi-center randomized clinical trial sponsored by National Institutes of Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to examine the efficacy and safety of methylphenidate as treatment for clinically significant apathy in AD participants. ADMET 2 will enroll participants from real world settings such as outpatient, nursing home, and assisted living facilities and will examine the effects of methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety monitoring.

NCT ID: NCT02340195 Completed - Alzheimer Disease Clinical Trials

Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects

NCT ID: NCT02337907 Completed - Alzheimer Disease Clinical Trials

BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Start date: January 21, 2015
Phase: Phase 2
Study type: Interventional

The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

NCT ID: NCT02336360 Completed - Alzheimer's Disease Clinical Trials

Augmenting Flortaucipir Dosimetry Estimates

Start date: January 2015
Phase: Phase 1
Study type: Interventional

This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.

NCT ID: NCT02333942 Completed - Alzheimer Disease Clinical Trials

Dementia Signal Development Study of Nautilus NeuroWave TM for the Detection of Dementia

Start date: May 2014
Phase:
Study type: Observational

This study is being performed to generate data regarding brain vibration /oscillation differences between individuals with dementia and normal controls. The purpose of this study is to compare signal patterns generated from the impact on the scalp from these brain oscillation patterns from individuals with Alzheimer's disease, Frontotemporal Lobar Degeneration, Mild Cognitive Impairment and Age-Matched Normal Controls.

NCT ID: NCT02331784 Completed - Clinical trials for Older Adults, Aging Brain

Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease

PACR-AD
Start date: April 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

NCT ID: NCT02323334 Completed - Healthy Volunteers Clinical Trials

A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease

Start date: December 2014
Phase: Phase 1
Study type: Interventional

This study involves single and multiple doses of LY3202626 and will evaluate the effects of LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single increasing doses of LY3202626 will be given in capsule form. Part A will also include itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days with the study drug. Part C will last approximately 11-14 weeks. Part D will last approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may only enroll in one part.

NCT ID: NCT02323217 Completed - Healthy Volunteers Clinical Trials

I2PETHV - Imidazoline2 Binding Site in Healthy Volunteers

I2PETHV
Start date: January 2015
Phase: Early Phase 1
Study type: Interventional

The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric conditions such as depression and addiction, along with neurodegenerative disorders such as Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated functional interactions with the opioid system, where I2BS ligands have been shown to affect tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats. Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects in different models of pain and a novel I2BS ligand, CR4056, is currently undergoing Phase II clinical trials as a novel treatment for neuropathic pain and acute non- specific pain states. The location of I2BS on astrocytic glial cells and the possibility that they may in some way regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been shown to increase in Alzheimer's disease post mortem, and it has also been suggested that I2BS may be a marker for the severity and malignancy of human glioblastomas. The lack of suitable imaging tools for the I2BS has meant that information regarding the number and distribution of I2BS in the brain has come from preclinical species and in vitro post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional distribution in the living human brain. In this study the investigators plan to utilise [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo using PET.

NCT ID: NCT02317523 Completed - Alzheimer Disease Clinical Trials

Alzheimer's Caregiver Coping: Mental and Physical Health

Start date: September 2014
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information.