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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
5
Subjects randomized to group A will receive Lexapro (escitalopram), in an initial, baseline dosage of 5 mg daily.
Subjects randomized to group B will receive Effexor XR (venlafaxine extended release capsules), in an initial baseline dosage of 37.5 mg daily.
Subjects randomized to group C will receive placebo tablets, which will be matched to the Lexapro and the Effexor XR as far as possible, and will also be administered on a once daily schedule at baseline.
New York University School of Medicine
New York, New York, United States
Z-score for the hippocampal region of interest in the theta band
responders show will less increase in score with treatment compared with baseline, in comparison with placebo treated subjects.
Time frame: 24 Months
Multivariate Z score for overall theta abnormality in the frontal and parieto-temporal regions;
Each subject can serve as their own control, z-transformed relative to initial values accessed for each of the endpoints. In addition, each subject can be evaluated relative to age-expected normal values.
Time frame: 24 Months
Probability of deterioration from logistic regression predictive of future decline;
Time frame: 24 Months
Z-score coherence (synchrony) between right central and parietal regions across all bands;
Each subject can serve as their own control, z-transformed relative to initial values accessed for each of the endpoints. In addition, each subject can be evaluated relative to age-expected normal values.
Time frame: 24 Months
Mean frequency across the total EEG brain spectrum.
Time frame: 24 Months
Metabolic reduction in the hippocampal formation (a region including the hippocampal subiculum and the entorhinal cortex) assessed bilaterally.
Time frame: 24 Months
Brief Cognitive Rating Scale Axes I to V total scores
Time frame: 24 Months
The Mini-Mental State Examination (MMSE) total scores
30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia.
Time frame: 24 Months
MAC-Q total score
brief index of memory complaint.
Time frame: 24 Months
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