Mild Cognitive ImpairmentPhase 3HIPNCT00539305
Hormone and Information Processing Study
A Phase 3 study testing testosterone gel in people with Mild Cognitive Impairment and Alzheimer's Disease, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years, men only
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care Systems
Seattle, Washington, 98108
About this study
Official title: Testosterone Supplementation in Men With MCI
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- testosterone gel, placebo gel
- Keywords
- selective androgen receptor modulators (SARMs), hormone replacement therapy, age-associated cognitive decline, testosterone supplementation
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone gelDrug
Also called Solvay Testosterone Gel
50-100mg applied topically daily for six months
placebo gelDrug
applied topically daily for six months
| Study group | Role | What they receive |
|---|---|---|
| Study drug; testosterone transdermal gel | Experimental | Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl Receives: Drug: testosterone gel |
| 2 | Placebo comparator | Not described Receives: Drug: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Solvay Pharmaceuticals
- Responsible party
- Principal investigator, Monique Cherrier, University of Washington
- Investigators
- Monique Cherrier, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539305
- Sponsor's protocol ID
- 29975-A
- Other IDs
- R01AG027156, 1R01AG027156-01A2
- Acronym
- HIP
- Status last verified
- Jul 2014
- First submitted
- 3 Oct 2007
- Last updated
- 14 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 11445632Cherrier 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.
PubMed 15668427Cherrier 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.
PubMed 15985573Cherrier 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.
PubMed 17145137Lu 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.
PubMed 16344336
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Supplementation in Men With MCI
- ClinicalTrials.gov ID
- NCT00539305
- Acronym / sponsor ID
- HIP / 29975-A
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- selective androgen receptor modulators (SARMs), hormone replacement therapy, age-associated cognitive decline, testosterone supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Solvay Pharmaceuticals
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Posted 14 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study drug; testosterone transdermal gel | Experimental | Drug: testosterone gelDose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl |
| 2 | Placebo comparator | Drug: placebo gel |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| testosterone gelAlso: Solvay Testosterone Gel50-100mg applied topically daily for six months | Drug | Study drug; testosterone transdermal gel |
| placebo gelapplied topically daily for six months | Drug | 2 |
Primary outcome
Behavioral & Mood Measure: Profile of Mood States (POMS)
Time frame: Baseline, 3 and 6 months
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
Time frame: Baseline, 3 and 6 months
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)
Time frame: Baseline, Month 3, Month 6
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)
Time frame: Baseline, Month 3, Month 6
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11445632Cherrier 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.
- Background: PubMed 15668427Cherrier 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.
- Background: PubMed 15985573Cherrier 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.
- Background: PubMed 17145137Cherrier 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.
- Background: PubMed 16344336Lu 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.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Alzheimer's Disease
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
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.
Monique Cherrier, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing testosterone gel in people with Mild Cognitive Impairment and Alzheimer's Disease, run by University of Washington 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 9 inclusion and 17 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 14 Jul 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Behavioral & Mood Measure: Profile of Mood States (POMS) (time frame: Baseline, 3 and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00539305, which also lists 5 linked publications.
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 14 Jul 2014.