Effects of testosterone on cognition and mood in male patients with mild Alzheimer disease and healthy elderly men.
BACKGROUND
There is a compelling need for therapies that prevent, defer the onset, slow the progression, or improve the symptoms of Alzheimer disease (AD).


OBJECTIVE
To evaluate the effects of testosterone therapy on cognition, neuropsychiatric symptoms, and quality of life in male patients with mild AD and healthy elderly men.


METHODS
Twenty-four-week, randomized, double-blind, placebo-controlled, parallel-group study.


METHODS
Memory disorders clinics as well as general neurology and medicine clinics from University of California medical centers at Los Angeles, San Francisco, and Irvine.


METHODS
Sixteen male patients with AD and 22 healthy male control subjects. Healthy elderly control men were recruited from the community through advertisements as well as through the university-based clinics.


METHODS
Testosterone and placebo, in the form of hydroalcoholic gel (75 mg), were applied daily to the skin of the participants.


METHODS
Instruments assessing cognitive functioning (Alzheimer's Disease Assessment Scale-Cognitive Subscale, California Verbal Learning Test, Block Design Subtest, Judgment of Line Orientation, Developmental Test of Visual-Motor Integration), neuropsychiatric symptoms (Neuropsychiatric Inventory), global functioning (Clinician's Interview-Based Impression of Change), and quality of life (Quality of Life-Alzheimer Disease Scale).


RESULTS
For the patients with AD, the testosterone-treated group had significantly greater improvements in the scores on the caregiver version of the quality-of-life scale (P = .01). No significant treatment group differences were detected in the cognitive scores at end of study, although numerically greater improvement or less decline on measures of visuospatial functions was demonstrated with testosterone treatment compared with placebo. In the healthy control group, a nonsignificant trend toward greater improvement in self-rated quality of life was observed in the testosterone-treated group (P = .09) compared with placebo treatment. No difference between the treatment groups was detected in the remaining outcome measures. Testosterone treatment was well tolerated with few adverse effects relative to placebo.


CONCLUSIONS
Results suggest that testosterone replacement therapy improved overall quality of life in patients with AD. Testosterone had minimal effects on cognition.
Lu
Po H
PH
Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles, USA. plu@mednet.ucla.edu
Masterman
Donna A
DA
Mulnard
Ruth
R
Cotman
Carl
C
Miller
Bruce
B
Yaffe
Kristine
K
Reback
Erin
E
Porter
Verna
V
Swerdloff
Ronald
R
Cummings
Jeffrey L
JL
D000339:Affect / Q000187:drug effects; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications*; D016022:Case-Control Studies; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011788:Quality of Life; D013739:Testosterone / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D016896:Treatment Outcome
D013739:Testosterone