New Approaches to Dementia Heterogeneity.
-
- STATUS
- Recruiting
Updated on 25 May 2021
cancer
stroke
depression
cognitive impairment
heart disease
aphasia
dementia
mild cognitive impairment
vascular dementia
amyotrophic lateral sclerosis
multiple sclerosis
dementia, frontotemporal
Summary
This
study is looking for adults who have mild
cognitive impairment, Alzheimer’s, or other forms of dementia. The study is also looking for
people with normal cognition, as a comparison. The study is interested in the
ways that brain function changes over time with the goal of improving the
ability to diagnose and care for dementia. This study is observational and
longitudinal, is entirely free of cost, and is offered in English, Spanish,
Mandarin, and Cantonese.
Description
Study
schedule:
At the start of the study:
-You will do cognitive tests.
-You will answer questions about your family history and health status.
-You will have a medical exam.
-You will give a blood sample.
-You may give a spinal fluid sample.
-You may have a brain scan (described below).
-During the study, you will repeat the study-start activities once a year.
-The study activities will require one or two visits to the study center each year.
At the start of the study:
-You will do cognitive tests.
-You will answer questions about your family history and health status.
-You will have a medical exam.
-You will give a blood sample.
-You may give a spinal fluid sample.
-You may have a brain scan (described below).
-During the study, you will repeat the study-start activities once a year.
-The study activities will require one or two visits to the study center each year.
In
addition:
-You will consider whether to participate in other research studies for which you may qualify.
-You will consider whether to donate your brain to science after your death.
-The study will end after about ten years.
Study activities may include:
-Doing cognitive tests and answering questions about your family history and health status. This may be in the form of interview-style conversations, paper-and pencil questionnaires, computer tests, and/or other activities.
-Having a medical exam.
-Having a sample of blood drawn from your arm vein, using a needle.
-Having a sample of spinal fluid drawn from your lower back (spine), using a needle. This is also known as a lumbar puncture or a spinal tap.
-Having a brain scan (described below).
-Considering whether to participate in other research studies.
-Considering whether to donate your brain to science after your death.
Treatment or experiment details:
-The brain scan is an MRI. For this, you will lie inside the scanning machine for about an hour while it takes a 3D image of your brain.
-There is no experiment or treatment being tested in this study.
-The study is interested in the ways that brain function changes over time in various forms of dementia.
Additional details:
-There is no cost for participating in the study. Free parking will be provided for study visits.
-You will consider whether to participate in other research studies for which you may qualify.
-You will consider whether to donate your brain to science after your death.
-The study will end after about ten years.
Study activities may include:
-Doing cognitive tests and answering questions about your family history and health status. This may be in the form of interview-style conversations, paper-and pencil questionnaires, computer tests, and/or other activities.
-Having a medical exam.
-Having a sample of blood drawn from your arm vein, using a needle.
-Having a sample of spinal fluid drawn from your lower back (spine), using a needle. This is also known as a lumbar puncture or a spinal tap.
-Having a brain scan (described below).
-Considering whether to participate in other research studies.
-Considering whether to donate your brain to science after your death.
Treatment or experiment details:
-The brain scan is an MRI. For this, you will lie inside the scanning machine for about an hour while it takes a 3D image of your brain.
-There is no experiment or treatment being tested in this study.
-The study is interested in the ways that brain function changes over time in various forms of dementia.
Additional details:
-There is no cost for participating in the study. Free parking will be provided for study visits.
-Visits take place at
UCSF’s Memory and Aging Center at the Mission Bay campus. In response to
COVID-19, some parts of the study may be done remotely via Telehealth.
Eligibility:
· You are 18 or older
· You
have a ‘study partner’—a family member, friend, or caregiver—who sees you often
and would be willing to help you with study activities, go with you on study
visits, and answer questions about you
· You either:
o Have mild cognitive impairment, Alzheimer’s, or another form of dementia
including behavioral variant frontotemporal dementia (bvFTD), primary
progressive aphasia (PPA),
semantic variant PPA (svPPA), FTD with amyotrophic lateral
sclerosis (FTD-ALS), corticobasal
degeneration (CBD), Creutzfeldt-Jakob
disease (CJD), dementia
with Lewy bodies (DLB), progressive
supranuclear palsy (PSP),
or another rapidly progressive dementia.
o
Are healthy and have normal cognition
You may not be eligible for this study if
· The results on your
study-start testing are outside of the ranges allowed by the study
· You
have a neurological, medical, or psychiatric condition, including brain infection, history of stroke, history
of head injury, seizures,
brain abnormalities, fluid in the brain, multiple sclerosis, multisystem atrophy, vitamin deficiency, advanced syphilis, HIV infection, heart disease, kidney disease, liver disease, lung disease, thyroid disease, cancer, anxiety, or dependence on drugs or alcohol
· You
cannot have an MRI, for example because of metal in your body
Details
| Condition | Dementia, Mild Cognitive Impairment, Alzheimer's Disease, *Healthy Volunteers, Frontotemporal Dementia |
|---|---|
| Clinical Study Identifier | TX249055 |
| Last Modified on | 25 May 2021 |
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What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
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Get screened
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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Step
3
Enroll in the clinical study
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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Step
4
Get your study results
Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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