Alzheimer's DiseaseNCT00392912
Effect of Testosterone Therapy in Men With Alzheimer's Disease and Low Testosterone
A study testing AndroGel (Solvay Pharmaceuticals) in people with Alzheimer's Disease and Hypogonadism, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial summary
Treatment with testosterone can improve performance on tests of spatial ability in men with low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean an improved ability to get around in one's environment without getting lost or injured. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Alzheimer's Disease, Hypogonadism
- What is being tested?
- AndroGel (Solvay Pharmaceuticals)
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimer's disease diagnosis, based on Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V)
- Total testosterone < 300 ng/dL and/or calculated free testosterone < 50 pg/ml
- Sufficient English to perform cognitive testing
- Stable on concomitant medications for 1 month prior to starting study
Who cannot join
- history of prostate cancer
- history of breast cancer
- gonadal endocrine disorders
- current major psychiatric illness (excluding depression)
- significant uncontrolled systemic illness
- recent myocardial infarction (within 6 months)
Show all 16Show fewer
- renal or hepatic disease, sleep apnea
- history of alcoholism or substance abuse within the past year
- history of head injury with loss of consciousness greater than 1 hour
- testosterone or other androgen treatment within past 3 months
- history of taking other drugs that might interfere with the results of the study (ie, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme inducers, barbiturates)
- symptomatic BPH: prostatic symptoms, prostatic masses or induration on rectal examination
- prostate specific antigen (PSA) >4.0 mg/mL
- hemoglobin > 17 mg/dL
- generalized skin disease that could affect the absorption of testosterone gel (ie, psoriasis).
- potentially agitated or uncooperative for procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease
Treatment with testosterone can improve performance on tests of spatial ability in men with low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean an improved ability to get around in one's environment without getting lost or injured. This could have a positive impact on both patients and those who care for them. We will investigate what areas of the brain are involved in these improvements in spatial ability. This will be done using a PET scan, which creates a 3-dimensional image of the brain that can allow us to see how the brain functions.
Read the detailed description
Volunteers will be treated with a prescription testosterone gel applied to the shoulder or other body area each day. This treatment will continue for 6 months. Subjects will undergo a PET scan at the beginning of the study and after approximately 2 months of treatment. Subjects will undergo some cognitive testing throughout the study.
- Conditions
- Alzheimer's Disease, Hypogonadism
- Being tested
- AndroGel (Solvay Pharmaceuticals)
- Keywords
- testosterone, hypogonadal, cerebral glucose metabolism, PET scan, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroGel (Solvay Pharmaceuticals)Drug
Also called AndroGel 1% 5g packets (Solvay Pharmaceuticals)
Testosterone Replacement Therapy: AndroGel 1% 5g packets (Solvay Pharmaceuticals). Initial dosage: 5g daily (1 packet). Patients who do not achieve eugonadal levels of 400-600 mg/dL within 2 weeks will be raised to 10g daily.
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated difference image of pre-treatment and on-treatment PET scans.
Secondary outcomes (1)
Change in cognitive function at 8-week intervals over a 6-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startApr 2007
- Primary completionNov 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Robert S. Tan, MD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392912
- Sponsor's protocol ID
- GR-294
- Status last verified
- Aug 2010
- First submitted
- 24 Oct 2006
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00392912
- Acronym / sponsor ID
- GR-294
- Conditions
- Alzheimer's Disease, Hypogonadism
- Keywords
- testosterone, hypogonadal, cerebral glucose metabolism, PET scan, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Apr 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment with testosterone can improve performance on tests of spatial ability in men with low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean an improved ability to get around in one's environment without getting lost or injured. This could have a positive impact on both patients and those who care for them. We will investigate what areas of the brain are involved in these improvements in spatial ability. This will be done using a PET scan, which creates a 3-dimensional image of the brain that can allow us to see how the brain functions.
Detailed description
Volunteers will be treated with a prescription testosterone gel applied to the shoulder or other body area each day. This treatment will continue for 6 months. Subjects will undergo a PET scan at the beginning of the study and after approximately 2 months of treatment. Subjects will undergo some cognitive testing throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Alzheimer's disease diagnosis, based on Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V)
- Total testosterone < 300 ng/dL and/or calculated free testosterone < 50 pg/ml
- Sufficient English to perform cognitive testing
- Stable on concomitant medications for 1 month prior to starting study
Key exclusion criteria (16 listed)
- history of prostate cancer
- history of breast cancer
- gonadal endocrine disorders
- current major psychiatric illness (excluding depression)
- significant uncontrolled systemic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndroGel (Solvay Pharmaceuticals)Also: AndroGel 1% 5g packets (Solvay Pharmaceuticals)Testosterone Replacement Therapy: AndroGel 1% 5g packets (Solvay Pharmaceuticals). Initial dosage: 5g daily (1 packet). Patients who do not achieve eugonadal levels of 400-600 mg/dL within 2 weeks will be raised to 10g daily. | Drug | – |
Primary outcome
Calculated difference image of pre-treatment and on-treatment PET scans.
1 secondary outcome
Change in cognitive function at 8-week intervals over a 6-month period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S. Tan, MD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AndroGel (Solvay Pharmaceuticals) in people with Alzheimer's Disease and Hypogonadism, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculated difference image of pre-treatment and on-treatment PET scans.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.