Phase 3 N=22 Randomized Quadruple-blind Treatment

Hormone and Information Processing Study

Mild Cognitive Impairment · Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00539305 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Behavioral & Mood Measure: Profile of Mood States (POMS) — 57.7; 55.5; -4.5; -0.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: testosterone gel (Drug); placebo gel (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: Male
Sponsor: University of Washington
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Behavioral & Mood Measure: Profile of Mood States (POMS)	57.7; 55.5; -4.5; -0.1; 1.9; -0.5	—
PRIMARY Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test	6.2; 4.9; 2.3; 0.0; 0.9; 1.5	—
PRIMARY Geriatric Depression Scale (GDS)	7.2; 4.1; 0.7; 2.3; -2.8; 2.7	—
PRIMARY Short-Form Health Survey (SF-36)	70.7; 85.6; 15.0; -3.8; 6.4; -5.4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00539305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.