A Proof of Concept Study of the Prevention of Mild Cognitive Impairment and Eventual Alzheimer's Disease Using F18 Flutemetamol
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 60 - 80 |
| Updated: | 10/24/2018 |
| Start Date: | July 11, 2017 |
| End Date: | January 2019 |
| Contact: | Anaztasia Ulysse |
| Email: | Anaztasia.Ulysse@nyumc.org |
| Phone: | (212)-263-0771 |
This is an investigator-initiated study comparing two types of FDA-approved anti-depressants,
Escitalopram and Venlafaxine, to placebo, in order to determine if these medications have
positive effects on cognition and memory in those who are between the ages of 50 to 89 years
old, who are cognitively normal, and who have subjective memory concerns. Research has shown
that those who are cognitively normal but report subjective cognitive impairment are more
likely to progress to mild cognitive impairment and Alzheimer's disease in the future.
Anti-depressants such as Escitalopram and Venlafaxine have been shown to stimulate production
of neurons in memory-sensitive areas such as the hippocampus. Therefore, the investigator is
researching whether these drugs would help cognition in those with subjective cognitive
impairment, and would help to prevent cognitive decline and eventual Alzheimer's disease.
Escitalopram and Venlafaxine, to placebo, in order to determine if these medications have
positive effects on cognition and memory in those who are between the ages of 50 to 89 years
old, who are cognitively normal, and who have subjective memory concerns. Research has shown
that those who are cognitively normal but report subjective cognitive impairment are more
likely to progress to mild cognitive impairment and Alzheimer's disease in the future.
Anti-depressants such as Escitalopram and Venlafaxine have been shown to stimulate production
of neurons in memory-sensitive areas such as the hippocampus. Therefore, the investigator is
researching whether these drugs would help cognition in those with subjective cognitive
impairment, and would help to prevent cognitive decline and eventual Alzheimer's disease.
Inclusion Criteria:
- Subjects must have subjective cognitive impairment (SCI) and be free of objective
evidence of cognitive impairment. Operationally, this will be defined as subjects with
Global Deterioration Scale (GDS) score of stage 2.4
- Subjects must be between 60 and 80 years of age.
- Subjects must have a knowledgeable informant (study partner) who can accompany them to
the evaluations, or, when necessary, be available for telephone contact.
- Subjects must be otherwise healthy and fulfill all of the inclusion criteria for
participation in the NYU ADC. Exclusion criteria are enumerated below.
- Subjects must be in a position to comply with all of the study procedures described
herein.
- Subjects must have a minimum of 12 years of education.
- Subjects must be fluent in English.
- Subjects original language at birth and/or, in childhood, must have been English,
alone, or in conjunction with other languages.
Exclusion Criteria:
- Subjects who have normal brain aging, who are free of subjective cognitive impairment
(SCI), and are therefore categorized at GDS stage 1, will be excluded.
- Subjects with MCI or dementia and are therefore categorized as being at GDS stage 3 or
greater, will be excluded.
- Subjects with a mini mental status examination (MMSE) score61 of ≤ 27 will be
excluded.
- Subjects with a Hamilton Depression Scale (HDS) score ≥ 16,62 signifying the presence
of notable depressive symptomatology which warrants treatment, will be excluded.
- Subjects with a primary diagnosis of depression or with a major depression diagnosis
will be excluded.
- Subjects with a significant medical, neurologic, or psychiatric condition, including
depression or anxiety disorder, that might interfere with cognition will be excluded.
- Subjects with a history of adverse reactions to escitalopram and/or venlaflaxine will
be excluded.
- Subjects, who are judged to have had adverse reactions to selective serotonin reuptake
inhibitor medications as a class, will be excluded.
- Subjects taking the antibiotic Zyvox (linezolid) or methylene blue therapy or who are
planning to have a diagnostic procedure utilizing methylene blue dye, will be
excluded.
- Subjects who are on psychoactive or cognitively active medications or who have
received such medications in the prior 8 weeks, will be excluded. These excluded
medications encompass antidepressant medications, antipsychotic medications,
anxiolytic medications, cholinesterase inhibitors, memantine, antiseizure medications,
antiparkinsonian medication and other CNS acting medications.
- Subjects who are receiving other medications or substances with reported neurogenic
enhancer or neurogenic inhibitor effects will not be excluded. The reason for this
inclusionary approach is that just as the effects of neurogenic enhancers on
Alzheimer's disease appears to be complex (specifically, likely useful in prevention,
possibly not useful effects on disease progression), the same complexity apparently
applies to substances with reported neurogenic enhancer or inhibitor effects. For
example, the angiotensin II receptor antagonist losartan has been reported to suppress
running enhanced neurogenesis in the rat.63 This same medication and medication class
has also been reported to be useful in improving memory64 and in the prevention of
Alzheimer's disease, possibly by other mechanisms.65
- Subjects with a history of significant cerebrovascular disease will be excluded. This
will be identified by one of the following:
i. history of stroke. ii. Any focal signs of significant neuropathology from the
neurological examination.
iii. A score of ≥ 4 on the Rosen modification of the Hachinski Ischemia Scale.66 iv. Focal
pathology on the MRI scan, indicative of history of infarction. l. Past history of brain
damage, seizure, mental retardation or serious neurological disorders.
- Significant history of alcoholism or drug abuse.
- Previous history of schizophrenia, mania, or major depression.
- Severe cardiac, pulmonary, vascular, metabolic, or hematologic conditions.
- Presence of a cardiac pacemaker.
- Presence of any metallic device or implant which would contraindicate an MRI (magnetic
resonance imaging) scan of the brain.
- Physical impairment of such severity as to adversely affect the validity of
psychological testing.
- Hostility or refusal to cooperate.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Barry Reisberg, MD
Phone: 212-263-0771
New York University School of Medicine NYU School of Medicine has a proud history that...
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