NCT00539305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 14, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

October 3, 2007

Results QC Date

March 15, 2013

Last Update Submit

July 10, 2014

Conditions

Mild Cognitive ImpairmentAlzheimer's Disease

Keywords

selective androgen receptor modulators (SARMs)hormone replacement therapyage-associated cognitive declinetestosterone supplementation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Study drug; testosterone transdermal gel

EXPERIMENTAL

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

Drug: testosterone gel

2

PLACEBO COMPARATOR
Drug: placebo gel

Interventions

testosterone gelDRUG

50-100mg applied topically daily for six months

Also known as: Solvay Testosterone Gel
Study drug; testosterone transdermal gel
placebo gelDRUG

applied topically daily for six months

2

Eligibility Criteria

Age60 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care Systems

Seattle, Washington, 98108, United States

Location

Related Publications (5)

  • 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.

    PMID: 11445632BACKGROUND

  • 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.

    PMID: 15668427BACKGROUND

  • 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.

    PMID: 15985573BACKGROUND

  • 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.

    PMID: 17145137BACKGROUND

  • 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.

    PMID: 16344336BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Monique Cherrier PhD.
Organization
University of Washington
cherrier@u.washington.edu
206-277-3594

Study Officials

  • Monique Cherrier, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 4, 2007

Study Start

July 1, 2009

Primary Completion

July 1, 2011

Study Completion

May 1, 2012

Last Updated

July 14, 2014

Results First Posted

July 14, 2014

Record last verified: 2014-07

Locations

US(1)