Hormone and Information Processing Study - Full Text View

Sponsors and Collaborators:	National Institute on Aging (NIA) Solvay Pharmaceuticals
Information provided by:	National Institute on Aging (NIA)
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 Impairment Alzheimer's Disease	Drug: testosterone gel Drug: placebo gel	Phase III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Testosterone Supplementation in Men With MCI

Further study details as provided by National Institute on Aging (NIA):

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:	60
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator	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: Christina Bradic	206-277-1155	cb80@u.washington.edu
Contact: Gareth Holman	206-277-5055	gholman@u.washington.edu

Locations

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

Sponsors and Collaborators

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:	University of Washington ( Monique Cherrier, PhD )
Study ID Numbers:	IA0124, 1R01AG027156-01 A2
Study First Received:	October 3, 2007
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00539305
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

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

Study placed in the following topic categories:

Testosterone
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Methyltestosterone

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Testosterone 17 beta-cypionate
Delirium

Additional relevant MeSH terms:

Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Hormones, Hormone Substitutes, and Hormone Antagonists
Tauopathies
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 30, 2009