Hormone and Information Processing Study - Full Text View

Sponsor:	University of Washington
Collaborators:	National Institute on Aging (NIA) Solvay Pharmaceuticals
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00539305

Purpose

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.

Condition	Intervention	Phase
Mild Cognitive Disorder Alzheimer's Disease	Drug: testosterone gel Drug: placebo gel	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Testosterone Supplementation in Men With MCI

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Mild Cognitive Impairment

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Behavioral & Mood measure: Profile of Mood States (POMS) [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
Cognitive changes measured by Neuropsychological tests: ADAS-Cog (MCI version), Route Test, Paragraph recall [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
Cerebrospinal Fluid (CSF) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
APOE genotyping [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl	Drug: testosterone gel 50-100mg applied topically daily for six months Other Name: Solvay Testosterone Gel
Placebo Comparator: 2	Drug: placebo gel applied topically daily for six months

Detailed Description:

Natural age related declines in testosterone (T) are associated with decreases in cognitive abilities independent of health status. Low T levels over time are associated with increased risk for developing Alzheimer's disease (AD). These findings suggest that men with low T levels are most at risk for age-related cognitive decline and AD and therefore most likely to benefit from T supplementation to prevent the development of AD or age-associated cognitive decline. The current study will assess cognition, mood, and cerebral spinal fluid (CSF) biomarker response to T supplementation in older men with mild cognitive impairment (MCI) and low T levels.

Participants will be randomized to either receive T treatment or a placebo for six months. Participants will come in for about five visits within the span of six months where they will complete cognitive & memory tests, fill out mood questionnaires, and have their blood drawn to monitor the medication level. A sample of blood will also be taken at one visit to test for apolipoprotein E (APOE), which is a genetic risk factor associated with AD. Participants will have the option to get a spinal tap in order to measure biological markers associated with Alzheimer's disease including beta-amyloid 1-40, 42, total-tau, and phosphorylated-tau-181-231. This will require an additional two visits.

Eligibility

Ages Eligible for Study:	60 Years to 90 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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), calcium, albumin, TSH, 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
GNRH antagonists
Flutamide
Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539305

Contacts

Contact: Ashley Holder, BS	206-277-1155	holdea@u.washington.edu
Contact: Nicole Myr	206-277-1041	myrn@u.washington.edu

Locations

United States, Washington
VA Puget Sound Health Care Systems	Recruiting
Seattle, Washington, United States, 98108

Sponsors and Collaborators

University of Washington

National Institute on Aging (NIA)

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Monique Cherrier, PhD

University of Washington

More Information

Publications:

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.

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.

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.

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.

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.

Responsible Party:	Monique Cherrier, PhD, University of Washington
ClinicalTrials.gov Identifier:	NCT00539305 History of Changes
Other Study ID Numbers:	29975-A, R01AG027156, 1R01AG027156-01 A2
Study First Received:	October 3, 2007
Last Updated:	February 25, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Washington:

selective androgen receptor modulators (SARMs)
hormone replacement therapy
age-associated cognitive decline
testosterone supplementation

Additional relevant MeSH terms:

Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Testosterone
Testosterone enanthate

Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 12, 2012