A Proof of Concept Study of the Prevention of Mild Cognitive Impairment and Eventual Alzheimer's Disease Using F18 Flutemetamol

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03274817

Enrollment

Registered

2017-09-07

Start date

2009-06-18

Completion date

2019-09-25

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease, Depression, Escitalopram, Venlafaxine

Brief summary

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.

Interventions

DRUGEscitalopram Pill

Subjects randomized to group A will receive Lexapro (escitalopram), in an initial, baseline dosage of 5 mg daily.

DRUGVenlafaxine Pill

Subjects randomized to group B will receive Effexor XR (venlafaxine extended release capsules), in an initial baseline dosage of 37.5 mg daily.

DRUGPlacebo Oral Tablet

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Metabolic reduction in the hippocampal formation (a region including the hippocampal subiculum and the entorhinal cortex) assessed bilaterally.	24 Months	—
Probability of deterioration from logistic regression predictive of future decline;	24 Months	—
Z-score coherence (synchrony) between right central and parietal regions across all bands;	24 Months	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.
Mean frequency across the total EEG brain spectrum.	24 Months	—
Z-score for the hippocampal region of interest in the theta band	24 Months	responders show will less increase in score with treatment compared with baseline, in comparison with placebo treated subjects.
Multivariate Z score for overall theta abnormality in the frontal and parieto-temporal regions;	24 Months	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.

Secondary

Measure	Time frame	Description
The Mini-Mental State Examination (MMSE) total scores	24 Months	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.
MAC-Q total score	24 Months	brief index of memory complaint.
Brief Cognitive Rating Scale Axes I to V total scores	24 Months	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026