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Hormone and Information Processing Study (HIP)

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
testosterone gel
placebo gel
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring selective androgen receptor modulators (SARMs), hormone replacement therapy, age-associated cognitive decline, testosterone supplementation

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • VA Puget Sound Health Care Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study drug; testosterone transdermal gel

2

Arm Description

Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2007
Last Updated
July 10, 2014
Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA), Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00539305
Brief Title
Hormone and Information Processing Study
Acronym
HIP
Official Title
Testosterone Supplementation in Men With MCI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA), Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer's Disease
Keywords
selective androgen receptor modulators (SARMs), hormone replacement therapy, age-associated cognitive decline, testosterone supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study drug; testosterone transdermal gel
Arm Type
Experimental
Arm Description
Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
testosterone gel
Other Intervention Name(s)
Solvay Testosterone Gel
Intervention Description
50-100mg applied topically daily for six months
Intervention Type
Drug
Intervention Name(s)
placebo gel
Intervention Description
applied topically daily for six months
Primary Outcome Measure Information:
Title
Behavioral & Mood Measure: Profile of Mood States (POMS)
Description
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.
Time Frame
Baseline, 3 and 6 months
Title
Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test
Description
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.
Time Frame
Baseline, 3 and 6 months
Title
Geriatric Depression Scale (GDS)
Description
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.
Time Frame
Baseline, Month 3, Month 6
Title
Short-Form Health Survey (SF-36)
Description
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.
Time Frame
Baseline, Month 3, Month 6

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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), 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Cherrier, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care Systems
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11445632
Citation
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.
Results Reference
background
PubMed Identifier
15668427
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. doi: 10.1212/01.WNL.0000149639.25136.CA.
Results Reference
background
PubMed Identifier
15985573
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. doi: 10.1212/01.WNL.0000165995.98986.F1.
Results Reference
background
PubMed Identifier
17145137
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. doi: 10.1016/j.psyneuen.2006.10.008. Epub 2006 Dec 4.
Results Reference
background
PubMed Identifier
16344336
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. doi: 10.1001/archneur.63.2.nct50002. Epub 2005 Dec 12.
Results Reference
background

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Hormone and Information Processing Study

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