Phase 2
N=27
Practice Effects and Amyloid Imaging Using 18F-PIB or Flutemetamol PET and FDG-PET
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01202994 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan. — 1.65 ratio of flutemetamol absorbed — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 18F-Flutemetamol (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan. |
1.65 | <0.05 sig |
| SECONDARY Change in Participant Z-score |
-0.07 | — |
Summary
Alzheimer's disease (AD) is the most common cause of progressive cognitive decline in the United States. AD is characterized by severe impairments in learning, memory and other cognitive abilities that significantly interfere with daily functioning. The neuropathologic hallmarks of AD consist of neuritic plaques, neurofibrillary tangles, and selective neuronal cell loss. Amyloid plaques, which contain Abeta protein, are believed to play an integral role in the development of AD. Elevated levels of Abeta in the brain are also correlated with cognitive decline.
Alzheimer's (AD) develops insidiously, making it difficult to identify early, yet treatment is most effective when begun during the early stages of the disease. Thus, it has become important for researchers to identify markers of early AD. This project will examine the relationship between four potential markers that may indicate the early development of AD:
1. Mild cognitive impairment (MCI)or normal cognition
2. Practice effects
3. Amyloid plaque binding on 18F-PIB PET
4. Glucose hypometabolism on FDG PET
This project will recruit 25 subjects from an ongoing community-based study of memory and practice effects in cognitively normal, community-dwelling individuals who are age 65 and over (NIA #5K23AG028417-05). Each subject will undergo positron emission tomography (PET) with both 18F-Flutemetamol and FDG.
The overall objective of this companion project is to study the biodistribution and binding of 18F-Flutemetamol in these subjects using PET imaging, which will provide biological evidence to support the overall hypothesis that failure to benefit from practice on a learning paradigm is an early marker of AD.
Eligibility Criteria
Inclusion Criteria
- Subjects must be currently enrolled in an NIA-sponsored, community-based study of practice effects in non-demented adults age 65 and older living independently (NIA #5K23AG028417-05)
Exclusion Criteria
- History of neurological disease known to affect cognition (e.g., stroke, head injury with loss of consciousness of >30 minutes, seizure disorder, demyelinating disorder, mental retardation, etc.)
- Dementia based on DSM-IV criteria
- Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder)
- 30-item Geriatric Depression Score >14
- Evidence of stroke or mass lesion on CT or MRI scan
- History of alcoholism or other substance abuse
- Current use of cholinesterase inhibitors, other cognitive enhancers, antipsychotics, or anticonvulsant medications
- History of radiation therapy to the brain
- History of significant major medical illnesses, such as cancer or AIDS
- Uncontrolled diabetes or blood glucose >180 mg/dl on the day of the FDG-PET scan
- Currently pregnant
Data sourced from ClinicalTrials.gov (NCT01202994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.