| Methods |
Randomized
Double‐blind
Placebo‐controlled
Parallel‐group
Duration: 12 weeks |
| Participants |
Country: United States
No. of centers: 5
Diagnosis: primary degenerative dementia
Diagnosis defined by: DSM‐III
Total No. of patients: 236
Age: Hydergine mean age was 69.8, range (55‐79), Placebo mean age was 68.5, range (55‐79)
Sex: Hydergine: 59 females, 43 males, Placebo: 46 females, 47 males.
Inclusion: Global deterioration score 2‐4; Hamilton Depression Rating Scale (HDRS) <17; normal pre‐treatment ECG, vitals, labs; no additional neurological or psychiatric diagnosis.
Exclusion: Significant abnormal findings that would interfere with study objectives. |
| Interventions |
Route: oral
Treatment: Hydergine 2mg t.i.d.
Control: Placebo t.i.d. |
| Outcomes |
GDS (Global Deterioration Scale), MMS (Mini Mental Status), HRDS (Hamilton), (Depression Rating Scale), SCAG (Sandoz Clinical Assessment Geriatric), IPSC‐E (Inventory of Psychic and Somatic Complaints), GDR (Geriatric Depression Rating Scale), DSST (Digit Symbol Substitution Test: subtest of WAIS: Wechsler)
Trail‐Making Test, BSRT (Buschke Selective Reminding Test), physical examination
labs, vitals, ECG, adverse reactions |
| Notes |
Initial 2 week single‐blind, placebo controlled design (prior to elegibility). No. excluded after randomization: Total = 41. Treatment = 17, Control = 24.
No. not included in analysis: Total: 41. Treatment = 17, Control = 24. |
