Status:
COMPLETED
Metformin in Amnestic Mild Cognitive Impairment
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Institute for the Study of Aging (ISOA)
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-90 years
Phase:
PHASE2
Brief Summary
Hyperinsulinemia and type 2 diabetes (T2D) are important potential risk factors for cognitive decline and Alzheimer's disease (AD). Two thirds of the US adult population are at risk for hyperinsulinem...
Detailed Description
The prevalence of Alzheimer's disease (AD) is expected to quadruple by the year 2047. There are no known curative or preventive measures for AD. Current treatment options for AD only address symptoms,...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age range: 55 years to 90 years. The main rationale for this inclusion criteria is to follow the standard set by the Alzheimer's Disease Cooperative Study (ADCS).
- Memory complaint expressed by the participant and recognized by the informant. The memory complaint must represent a change from previous functioning based on information provided by both subject and informant.
- Fluent in English or Spanish.
- Mini-Mental State Examination (MMSE) equal or more than 20.
- Subjects must fulfill criteria for amnestic mild cognitive impairment (MCI). Guidelines for the diagnosis of MCI: Subjects must score below a predetermined cut-off score on the logical memory II delayed paragraph recall sub-test of the Wechsler Memory Scale Revised (WMS-R) or the selective reminding test (SRT).
- Global Clinical Dementia Rating (CDR) score must be 0.5 at screening.
- Subjects without a known history of diabetes or diabetes that has never been treated with medications. If diabetes is diagnosed during screening or they have a history of diabetes not treated in the last 12 months they will be excluded if their Hemoglobin A1c (HbA1c) is \> 6.5. In addition, a diagnosis of diabetes can be made if the HbA1c is 6.5% or more.
- Overweight or obese by National Heart, Lung, and Blood Institute (NHLBI) criteria (Body Mass Index (BMI) of more or equal of 25 kg/ m2).
- No contraindications to metformin treatment.
- Hachinski score less or equal to 4.
- Hamilton score less or equal to 12 on the 17 item scale.
- General cognition and functional performance such that a diagnosis of dementia cannot be made at the time of screening based on DSM-IV criteria.
- Vision and hearing must be sufficient for compliance with testing procedures.
- Exclusion criteria:
- Individuals with dementia
- MMSE \< 20
- Subjects with neurologic diseases associated to neurologic deficits.
- Subjects with current psychiatric diagnoses such as depression, bipolar disorder or schizophrenia.
- Subjects with uncontrolled hypertension (systolic blood pressure more than 160 mmHg or diastolic blood pressure more than 95 mmHg.
- Subjects with a history of active cancer or cancer within last five years, with the exception of squamous or basal cell carcinoma of the skin.
- Subjects who for any reason may not complete the study as judged by the study physician.
- Subjects with a known history of diabetes treated with medications.
- Subjects with a new or old diagnosis of diabetes, never treated, with a HbA1c of more than 6.5 .
- Contraindications to metformin: Contraindications to metformin use include a creatinine of \> 1.5, liver disease by history or by elevated transaminases, congestive heart failure, and alcohol abuse.
- Use of cholinesterase inhibitors.
- Exclusion criteria for brain imaging study:
- Presence of diabetes, even if the HbA1c is less or equal to 6.5.
- Inability to lie down for any reason.
- Presence of any metallic implant.
- Claustrophobia.
- Any contraindication to magnetic resonance imaging (MRI) or fluorodeoxyglucose (FDG) positron emission tomography (PET).
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00620191
Start Date
June 1 2008
End Date
February 1 2012
Last Update
October 23 2020
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032