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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_547 |
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The aim of the study is to determine if regional cerebral blood flow, measured by dynamic arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's disease, and participants with normal cognition. Various imaging studies will be done using magnetic resonance imaging (MRI) and positron emission tomography (PET) along with neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8 study visits. Repeat imaging studies may be required if the initial data are incomplete or un-interpretable. The maximum number of PET scans during the study will be limited to four.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD Participants | Experimental | Participants with a diagnosis of mild-to-moderate AD |
|
| Cognitively Normal Elderly Participants | Experimental | Elderly participants with no cognitive impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional cerebral blood flow, as measured by dASL. | Part I: regional cerebral blood flow, measured by dASL at Baseline and 1 week in AD participants and cognitively normal controls. Part II: regional cerebral blood flow, measured at 6 months and 12 months in AD participants and normal control participants. | 1 week, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET) | Regional cerebral rate of glucose consumption, MRglc, as assessed by FDG-PET will be measured at Baseline in (Part I) and at 12 months in (Part II), in AD participants and normal control participants. | 12 months |
| Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response |
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Inclusion Criteria:
The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.
The participant:
Exclusion Criteria:
If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
The participant:
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| FDG-PET | Other | 2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable |
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The resting state fMRI BOLD (blood-oxygen-level-dependent) signal will be evaluated for 'Goodness-of-Fit' to the default mode network at Baseline, 1 week, and 6 and 12 months in AD participants and normal control participants. |
| 1 week, 6 and 12 months |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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