Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG027156 | U.S. NIH Grant/Contract | View source | |
| 1R01AG027156-01A2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Solvay Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study drug; testosterone transdermal gel | Experimental | Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| testosterone gel | Drug | 50-100mg applied topically daily for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Prohibited Medications:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monique Cherrier, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care Systems | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11445632 | Background | 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. doi: 10.1212/wnl.57.1.80. | |
| 15668427 | Background | 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. doi: 10.1212/01.WNL.0000149639.25136.CA. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months |
| FG001 | Placebo Group | Placebo gel : applied topically daily for six months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Vigor-Activity | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 and 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PSA elevated above 4.0 ng/ml | General disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Cherrier PhD. | University of Washington | 206-277-3594 | cherrier@u.washington.edu |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo gel | Drug | applied topically daily for six months |
|
| 15985573 | Background | 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. doi: 10.1212/01.WNL.0000165995.98986.F1. |
| 17145137 | Background | 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. doi: 10.1016/j.psyneuen.2006.10.008. Epub 2006 Dec 4. |
| 16344336 | Background | 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. doi: 10.1001/archneur.63.2.nct50002. Epub 2005 Dec 12. |
| Withdrawal by Subject |
|
Placebo gel : applied topically daily for six months
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo gel : applied topically daily for six months
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, Month 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, Month 6 |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Placebo Group | Placebo gel : applied topically daily for six months | 0 | 12 | 0 | 12 |
| Emergency room with chest pains | General disorders | Pain stopped within 10-15 minutes, patient was not admitted to hospital and is following up with his personal physician. |
|
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| Month 6 (Change from Baseline) |
|
| Month 6 (Change from Baseline) |
|
| Month 6 (Change from Baseline) |
|