Alzheimer's Disease clinical trials at UCSD
15 in progress, 8 open to eligible people
AAV2-BDNF Gene Therapy in Early Alzheimer's Disease and Mild Cognitive Impairment
open to eligible people ages 50-80
This is a first-in-human clinical trial to test whether a protein administered into the brain continuously by gene therapy, Brain-Derived Neurotrophic Factor (BDNF), will slow or prevent cell loss in the brains of people affected by Alzheimer's disease and Mild Cognitive Impairment. The protein may also activate cells in the brain that have not yet deteriorated. Gene therapy refers to the use of a harmless virus to have brain cells make the potentially protective protein, BDNF.
La Jolla, California and other locations
Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
open to eligible people ages 18 years and up
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.
La Jolla, California and other locations
Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
open to eligible people ages 50-83
The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested
San Diego, California
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001
open to eligible people ages 18-80
The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.
La Jolla, California and other locations
Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
open to eligible people ages 65-85
Obstructive sleep apnea (OSA) is common in older adults and has recently been implicated in pathogenesis of Alzheimer's disease (AD). Research has shown that sleep disruptions have caused memory impairment. Sleep apnea is a form of sleep disruption. We would like to examine how obstructive sleep apnea may contribute to the progression of Alzheimer's disease.
La Jolla, California
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
open to eligible people ages 55-89
In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week).
San Diego, California
Diagnostic Test for Dementia With Lewy Bodies
open to eligible people ages 50-85
The Syn-D Study will be evaluating α-synuclein in patients with suspected MCI-AD and MCI-DLB. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.
La Jolla, California and other locations
Alzheimer's Disease Neuroimaging Initiative 4
open to eligible people ages 55-90
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.
La Jolla, California and other locations
JNJ-63733657 in Participants With Early Alzheimer's Disease
Sorry, in progress, not accepting new patients
The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.
La Jolla, California and other locations
Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation
Sorry, not yet accepting patients
The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Part 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Part 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.
La Jolla, California and other locations
Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age
Sorry, in progress, not accepting new patients
In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD. The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most. To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB. - Clinicians use the CDR-SB to measure several categories of dementia symptoms. - The results for each category are added together for a total score. Lower scores are better. Researchers will also learn more about the safety of BIIB080. The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension (LTE) Period. The 2nd part of the study will help researchers learn about the long-term safety of BIIB080, and how it affects the participant's daily life, thinking, and memory abilities in the longer term. A description of how the study will be done is given below. - After screening, participants will first receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine. - Participants will receive BIIB080 or placebo once every 12 weeks or 24 weeks. - After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks. - In the extension period, participants who received placebo will be switched to high dose BIIB080 every 12 or 24 weeks. - Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods. - Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period. - After the screening period, most participants will visit the clinic every 6 weeks.
San Diego, California and other locations
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)
Sorry, in progress, not accepting new patients
To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.
La Jolla, California and other locations
TREAD: Time Restricted Eating Intervention for Alzheimer's Disease
Sorry, not yet accepting patients
The goal of this clinical trial is to learn if restricting the time of eating to allow for prolonged fasting at night may reduce sleep disturbances, cognitive decay, and pathology in patients diagnosed with Mild Cognitive Impairment (MCI) or early to moderate Alzheimer's disease (AD). It will also learn about the feasibility of practicing 14 h of nightly fasting in this group of older adults. The main questions it aims to answer are: - Does prolonged nightly fasting of 14 h can reduce markers of AD pathology and aging and reduce cognitive and sleep alterations in MCI and AD patients? - Can patients with MCI and early /moderate AD sustain time-restricted eating for 6 to 12 months? Researchers will compare participants who fast for 14 h per night during 6 months to those who fast for less than 10 h/night. Researchers will also compare participants that fast for 6 months to those who fast during 12 months, to determine the effective duration of the intervention. Finally, researchers will evaluate whether following the time-restricted eating diet alongside a partner actively following the same diet, will increase adherence to the protocol compared to subjects that fast alone. Participants will: - Fast for 14 h a night (stop eating at 8 pm and start eating the following morning at 10 am) for 6 or 12 months - Visit the clinic three times (at the beginning of the study, 6 and 12 months later) - Provide blood samples and take a cognitive test during clinic visits - Keep a diary (or use an app on a smart phone) to record time of eating - Wear an activity tracker watch
San Diego, California
Environmental and Reproductive Health Risk for Lewy Body Dementia
Sorry, in progress, not accepting new patients
The goal of this survey study is to identify environmental, occupational and reproductive health risk factors for Lewy body dementia, which includes Parkinson's disease dementia and dementia with Lewy bodies. Participants will complete a one-time survey online or over the phone that includes questions on environmental, occupational factors they may have been exposed to and on medical history including reproductive health. Researchers will then compare the responses of people with Lewy body dementia and people without Parkinson's or memory/thinking problems to see which factors play a role in Lewy body dementia. Identifying risk factors can guide future treatment efforts and provide more insight to this dementia.
La Jolla, California
Diabetes Prevention Program Outcomes Study AD/ADRD Project
Sorry, accepting new patients by invitation only
The DPPOS AD/ADRD project will address the overarching question: What are the determinants and the nature of cognitive impairment among persons with pre-diabetes (PreD) and type 2 diabetes (T2D), who are a high-risk group for cognitive impairment and represent a large fraction of the United States (US) population? This U19 proposal addresses the National Alzheimer's Project Act goal to "prevent, halt, or reverse AD" in the high-risk group of persons with pre-diabetes and type 2 diabetes, who represent over half of the population aged 60 years and older in the US.
San Diego, California and other locations
Our lead scientists for Alzheimer's Disease research studies include David Coughlin, MD Atul Malhotra Doug Galasko Zvinka Z Zlatar, PhD Neal Swerdlow, M.D., Ph.D. Mark Tuszynski, M.D., Ph.D. Paula Desplats, PhD.
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