Mild Cognitive Impairment Clinical Trial
— HIPOfficial title:
Testosterone Supplementation in Men With MCI
Verified date | July 2014 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to examine the effects of testosterone (T) replacement on changes in thinking and memory, as well as mood in older men with mild cognitive impairment (MCI) and low T levels. The study will also examine whether taking testosterone has effects on biological markers related to Alzheimer's disease.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 2012 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 60 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Male 60-90 years of age - Diagnosis of mild cognitive impairment (MCI) - Low testosterone level - Primary language is English - Availability of an informant who knows the participant well enough to answer questions - Stable medications for the previous 3 months - Normal complete blood count (CBC), and no clinically significant blood chemistry - American Urological Association (AUA) symptom score less than or equal to 19 - Body Mass Index (BMI) less than 33 and stable weight in the previous year Exclusion Criteria: - Prior history of prostate cancer or prostate specific antigen level greater than 4.0ng/ml - Peripheral or vascular disease - Significant history of alcohol abuse, current alcohol abuse (more than 2 drinks per day), or other substance abuse - History of severe head injury (with loss of consciousness greater than 30 minutes) - Significant neurological illness, such as Parkinson's disease, seizure disorder, multiple sclerosis, major stoke - Smokes cigarettes - Major psychiatric illness, such as schizophrenia or bipolar disorder Prohibited Medications: - Anti-convulsants - Anti-psychotics - Sedating antihistamines - Sedative/hypnotics - Benzodiazepines - Hormone or testosterone regimens - Gonadotropin-releasing hormone (GNRH) antagonists - Flutamide - Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care Systems | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute on Aging (NIA), Solvay Pharmaceuticals |
United States,
Cherrier MM, Asthana S, Plymate S, Baker L, Matsumoto AM, Peskind E, Raskind MA, Brodkin K, Bremner W, Petrova A, LaTendresse S, Craft S. Testosterone supplementation improves spatial and verbal memory in healthy older men. Neurology. 2001 Jul 10;57(1):80-8. — View Citation
Cherrier MM, Matsumoto AM, Amory JK, Ahmed S, Bremner W, Peskind ER, Raskind MA, Johnson M, Craft S. The role of aromatization in testosterone supplementation: effects on cognition in older men. Neurology. 2005 Jan 25;64(2):290-6. — View Citation
Cherrier MM, Matsumoto AM, Amory JK, Asthana S, Bremner W, Peskind ER, Raskind MA, Craft S. Testosterone improves spatial memory in men with Alzheimer disease and mild cognitive impairment. Neurology. 2005 Jun 28;64(12):2063-8. — View Citation
Cherrier MM, Matsumoto AM, Amory JK, Johnson M, Craft S, Peskind ER, Raskind MA. Characterization of verbal and spatial memory changes from moderate to supraphysiological increases in serum testosterone in healthy older men. Psychoneuroendocrinology. 2007 Jan;32(1):72-9. Epub 2006 Dec 4. — View Citation
Lu PH, Masterman DA, Mulnard R, Cotman C, Miller B, Yaffe K, Reback E, Porter V, Swerdloff R, Cummings JL. Effects of testosterone on cognition and mood in male patients with mild Alzheimer disease and healthy elderly men. Arch Neurol. 2006 Feb;63(2):177-85. Epub 2005 Dec 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behavioral & Mood Measure: Profile of Mood States (POMS) | Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline. | Baseline, 3 and 6 months | No |
Primary | Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test | Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline. | Baseline, 3 and 6 months | No |
Primary | Geriatric Depression Scale (GDS) | Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline. | Baseline, Month 3, Month 6 | No |
Primary | Short-Form Health Survey (SF-36) | Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale. | Baseline, Month 3, Month 6 | No |
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