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Trial record 94 of 103 for:    "Kennedy disease"

Hormone and Information Processing Study (HIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00539305
Recruitment Status : Completed
First Posted : October 4, 2007
Results First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Monique Cherrier, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Mild Cognitive Impairment
Alzheimer's Disease
Interventions Drug: testosterone gel
Drug: placebo gel
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description

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

Placebo gel : applied topically daily for six months
Period Title: Overall Study
Started 10 12
Completed 9 10
Not Completed 1 2
Reason Not Completed
Adverse Event             1             0
Substance Use             0             1
Withdrawal by Subject             0             1
Arm/Group Title Treatment Group Placebo Group Total
Hide Arm/Group Description

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

Placebo gel : applied topically daily for six months Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  20.0%
4
  33.3%
6
  27.3%
>=65 years
8
  80.0%
8
  66.7%
16
  72.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 12 participants 22 participants
71.2  (9.1) 70.0  (7.7) 70.5  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
12
 100.0%
22
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 12 participants 22 participants
10 12 22
1.Primary Outcome
Title Behavioral & Mood Measure: Profile of Mood States (POMS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Vigor-Activity
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

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

Placebo gel : applied topically daily for six months
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 57.7  (2.2) 55.5  (2.0)
Month 3 (Change from Baseline) -4.5  (2.8) -0.1  (2.4)
Month 6 (Change from Baseline) 1.9  (2.7) -0.5  (2.5)
2.Primary Outcome
Title Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

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

Placebo gel : applied topically daily for six months
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.2  (1.1) 4.9  (1.0)
Month 3 (Change from Baseline) 2.3  (0.9) 0.0  (0.8)
Month 6 (Change from Baseline) 0.9  (0.9) 1.5  (0.8)
3.Primary Outcome
Title Geriatric Depression Scale (GDS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

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

Placebo gel : applied topically daily for six months
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.2  (1.3) 4.1  (1.2)
Month 3 (Change from Baseline) 0.7  (1.5) 2.3  (1.3)
Month 6 (Change from Baseline) -2.8  (1.5) 2.7  (2.3)
4.Primary Outcome
Title Short-Form Health Survey (SF-36)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

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

Placebo gel : applied topically daily for six months
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 70.7  (10.4) 85.6  (2.3)
Month 3 (Change from Baseline) 15.0  (9.4) -3.8  (6.4)
Month 6 (Change from Baseline) 6.4  (8.6) -5.4  (3.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description

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

Placebo gel : applied topically daily for six months
All-Cause Mortality
Treatment Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      0/12 (0.00%)    
General disorders     
PSA elevated above 4.0 ng/ml  1/10 (10.00%)  1 0/12 (0.00%)  0
Emergency room with chest pains [1]  1/10 (10.00%)  1 0/12 (0.00%)  0
[1]
Pain stopped within 10-15 minutes, patient was not admitted to hospital and is following up with his personal physician.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Monique Cherrier PhD.
Organization: University of Washington
Phone: 206-277-3594
Responsible Party: Monique Cherrier, University of Washington
ClinicalTrials.gov Identifier: NCT00539305     History of Changes
Other Study ID Numbers: 29975-A
R01AG027156 ( U.S. NIH Grant/Contract )
1R01AG027156-01A2 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2007
First Posted: October 4, 2007
Results First Submitted: March 15, 2013
Results First Posted: July 14, 2014
Last Update Posted: July 14, 2014