| Methods |
Randomized
Double‐blind
Parallel‐group
Placebo‐controlled
Duration: 24 weeks |
| Participants |
Country: Netherlands
No. of centers: 3
Diagnosis: mild‐moderate senile mental deterioration
Diagnosis defined by: SCAG (Sandoz Clinical Assessment Geriatric Scale)
Total No. of patients: 58
Setting: Old‐peoples homes
Age: Hydergine mean age = 83.7, Placebo mean age = 82.7
Sex: unclear
Inclusion: geriatric residents diagnosed with mild‐moderate senile mental deterioration, including SCAG scores of 3‐5 on >5 symptoms and 4‐5 on >2 key symptoms and HIS (Hachinski Ischemic Score) of <7.
Exclusion: HIS >7; psychiatric, neurologic, or other severe systemic disorders; vasodilator or CNS medications; SCAG score of 7 on 1 or more items. |
| Interventions |
Route: oral
Treatment: Hydergine 1.5mg t.i.d. (1st 12 wks) and Hydergine 1.5mg (AM) and 3mg b.i.d. (Noon and PM) for 2nd 12wks.
Control: Placebo t.i.d. |
| Outcomes |
SCAG
Behavior, assessed by 45 min. conversation
Hamburg Wechsler Adult Intelligence Scale subtests:
Digit Span
Digit Symbol
Block Design
Labyrinth Test
Benton Visual Retention
Trails A & B
Questionnaires on biographical data, activities of daily living, personality, and activities
Physical examination, labs, vitals, ECG |
| Notes |
No. excluded after randomization: Total = 8. Treatment = 2, Control = 6.
No. not included in analysis: Total = 8. Treatment = 2, Control = 8. |
