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85 active trials for Alzheimer's Disease

A Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers to Evaluate Efficacy and Safety in the Treatment of Autosomal-Dominant Alzheimer's Disease (AD), Including a Placebo-Treated Non-Carrier Cohort

This randomized, double-blind, placebo-controlled, parallel group, adaptive study will evaluate the efficacy and safety of crenezumab versus placebo in individuals who carry the PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive impairment due to AD or dementia due to AD and are, thus, in a preclinical phase of AD. Participants will be randomized in a 1:1 ratio to receive either crenezumab or placebo subcutaneously (every 2 weeks) or intravenously (every 4 weeks) for at least 260 weeks. The switch to the intravenous (IV) dose will be optional (as per participant decision). The study will also include a cohort of PSEN1 E280A mutation non-carriers who will be dosed with placebo only.

Start: December 2013

New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.

Start: December 2020

Phase 2 Study to Examine Grape Seed Extract as an Anti-Oligomerization Agent in Alzheimer's Disease (AD)

Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia. Our proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD subjects. As secondary measures, we will also provide the essential human data to guide the design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration in AD patients.

Start: November 2014

Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia

This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).

Start: April 2018

Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)

This study compares different music therapy (MT) experiences and their impact on memory and language in patients with Alzheimer's disease and Mild Cognitive Impairment. The 12-month study will assess the role of common experiences involving familiar music and other pleasant events (blinded control) to benefit cognition and measure the quality of life for people with Alzheimer's disease and Mild Cognitive Impairment. Following screening, all participants will meet with a licensed music therapist at the first study visit. Thereafter, each group will have an individualized schedule of follow-up telephone calls and visits. Screening for the study and participation in the study intervention can be completed in-person or from your home, if you do not live in the area.

Start: July 2019

Microglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's Disease

The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) A pilot substudy aims to establish the non-inferiority of [F-18]PBR06 as compared with Carbon-11 [C-11] labeled "Peripheral Benzodiazepine Receptor 28" (PBR28) PET in patients with RRMS. Hypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities. In addition, the investigators hypothesize that [F-18]PBR06-PET scans will be at least as good as [C-11]PBR28-PET scans, the current gold standard.

Start: May 2016

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

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.

Start: October 2015

A Study to Evaluate the Pharmacokinetics and Safety of BEY2153 in Healthy Participants

This is a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153.

Start: August 2020

BEAM: Brain-Eye Amyloid Memory Study

The main objectives for this study are: To investigate novel, non-invasive ocular measurements including optical coherence tomography and eye tracking in a cross-sectional study of participants with various neurodegenerative dementias against standard cognitive assessments and brain imaging measures; and To assess the potential utility of ocular assessments for early detection in the pre-dementia, i.e. the so-called Mild Cognitive Impairment (MCI) stage, across the common neurodegenerative dementia syndromes and, Vascular Cognitive Impairment (VCI) due to small vessel disease (SVD). To determine the prevalence and relevance of amyloid uptake on PET scanning across the dementias most commonly associated with amyloidosis. Specifically we aim to examine correlations with amyloid uptake status in patients symptomatic from the most common proteinopathies (ie amyloid, tau, synuclein) combined in varying degrees with the most common vasculopathies (ie small vessel disease) using multimodal structural and functional imaging, cognitive behavioral, and gait and balance measures, taking into account genetic risk markers (particularly apolipoprotein E genotypes) and fluid biomarkers ( eg cytokines, oxidative stress, lipidomics).

Start: February 2016

Autobiographical Memory

This study aims at the assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.

Start: November 2020

Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease

The study is designed to characterize the clinical, neuropsychological, polysomnographic, and neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and Parkinsons' Disease.

Start: August 2018

Impact of Controlling Vascular Risk Factors on the Progression of Alzheimer's Disease

Three quarters of patients with Alzheimer's disease have at least one vascular risk factor (VRF). Vascular brain lesions are present in most Alzheimer's patients (especially older ones). This cerebrovascular disease potentiates Alzheimer's lesions in early-stage disease. Many research studies have shown that VRFs are also risk factors for Alzheimer's disease; this is true for arterial hypertension and dyslipidaemia in particular and, to a lesser extent, diabetes and cardiopathy. Moreover, recent drug trials (SYST-EUR, PROGRESS and HOPE) have indicated that antihypertensive medications can prevent the appearance of dementia (and notably Alzheimer's disease) in over-60 hypertensive subjects. An observational study of 233 Alzheimer's patients with an average follow-up period of 4 years has shown that the annual decline in the Mini-Mental State Examination (MMSE) score was lower in patients in whom all the VRFs were being treated than in patients in whom no VRFs were being treated (1.5 ± 2.5 points versus 2.5 ± 2 points, respectively; p<0.04).1 However, it is not currently known whether optimal treatment of VRFs can influence the progression and prognosis of Alzheimer's disease. Answering this question could have a significant impact on public health.

Start: March 2010

n-3 PUFA for Vascular Cognitive Aging

Brain scans can help identify changes that appear to increase risk for cognitive decline and dementia. Some of these brain changes are thought to reflect actual damage to the small blood vessels that support normal brain function. This clinical trial will determine whether an omega 3 polyunsaturated fatty acid (PUFA) therapy can promote brain health by supporting the small blood vessels in the brain over 3 years in older adults at high risk for cognitive decline and dementia of Alzheimer's type.

Start: May 2014

Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability

Patients with Alzheimer's disease (AD) can have seizures in addition to losing their memory and other mental functions (referred to as cognitive functions). The seizures, and other examples of overactive electrical activity in the brain that is not noticeable, contribute to the loss of cognitive function. Studies in animal models of AD suggest that a drug that prevents seizures called levetiracetam may reduce neuronal over-excitation and improve cognition. Based on this evidence, the investigators propose to determine if levetiracetam can be used to treat patients with AD. The investigators developed novel instruments for this population that will also be used in future large-scale clinical trials. The current study will last for 12 weeks and will involve people with AD. Participants will be initially examined with an overnight brain wave study to assess for silent epileptic (seizure-like) activity. Presence of epileptic activity on the screening exam is not required to enter the trial. Participants will then be assigned to groups in a randomized manner. One group will receive levetiracetam for 4 weeks, then no drug for 4 weeks, and then placebo for 4 weeks. For another group, the order of treatments will be reversed. The cognitive abilities of participants will be retested every 4 weeks and compared to those at the beginning. The cognitive tests include a virtual-reality navigation test of memory and computerized tests of mental flexibility and problem solving. The participants will be monitored with a magnetoencephalogram (MEG) with simultaneous EEG (M/EEG) at each visit. M/EEG is a highly effective non-invasive method for identifying brain regions of epileptic activity. The investigators will need to recruit 36 randomized participants to test the study hypotheses. This study will take place at the University of California, San Francisco (UCSF) and the University of Minnesota.

Start: June 2014

Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.

A long-term follow-up study to obtain safety and efficacy data in subjects who completed phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups for up to 36 months after the initial administration in patients suffering from Alzheimer's disease

Start: May 2017

Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease

This study is designed to assess the safety and toxicity/adverse events associated with the use of low dose fractionated whole brain irradiation in those patients who have been diagnosed with probable Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. As a secondary goal it will establish whether or not the intervention with low dose whole brain irradiation might change the recognized progression of Alzheimer's Disease. The investigators will also collect information from the AMYVID ® (florbetaben F 18 Injection) positron emission tomography (PET) Scans to determine if there is any correlation between neurocognitive/quality of life scores and changes in amyloid plaque size, number and location.

Start: October 2019

Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease

This study evaluates the safety and pharmacological effects of 3 different doses of Posiphen® when compared to a placebo, in adult male and female patients with early Alzheimer's disease (AD).

Start: March 2017

A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease

The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. is the key and difficult points in AD research. Except expensive brain ? amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. [18F]-AV-45 plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD. Next, a pilot intervention study on APP/PS1 transgenic mice will be promoted based on miRNAs gene regulation.

Start: March 2020

Imaging Inflammation in Alzheimer's Disease

This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and do tests to measure the participants' memory and thinking.

Start: June 2016

Benfotiamine in Alzheimer's Disease: A Pilot Study

General Investigational Plan Study Objectives The goal of this proposal is to determine whether enhancing brain glucose utilization minimizes cognitive decline in patients with Amnestic Mild Cognitive Impairment (AMCI) or mild Alzheimer's disease (AD) dementia. We propose a proof of concept double-blind, placebo controlled pilot study to determine if increasing brain thiamine availability with the investigational new drug benfotiamine, will minimize the decline in glucose utilization and slow the cognitive decline associated with the progression AMCI/AD dementia. Specifically, our objectives are two-fold: To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG). To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate. We will also carry out the following secondary objectives: Assess if there are differences in secondary clinical outcome measures (NPI, ADCSADL, CDR, Buschke) between benfotiamine and placebo groups and whether specific cognitive domains (ie: activities of daily living, learning and memory verbal memory, behavioral, etc.) are driving these changes. Compare ADAS-COG change scores in the benfotiamine and placebo groups within and between strata that were defined by initial cognitive impairment, to attempt to identified the population that most benefits from benfotiamine. Compare changes in glucose utilization between the benfotiamine and placebo groups in secondary Regions of Interest (ROIs) including the hippocampus, prefrontal regions and entorhinal cortex. Compare changes in whole brain glucose utilization between the benfotiamine and placebo groups using statistical parametric mapping (SPM). Assess the correlation between changes in glucose utilization with changes in ADAS Cog. Determine if ApoE4 genotype alters the response to benfotiamine.

Start: November 2014